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Approved IDE Studies

The following IDE studies have met CMS’ standards for coverage. Studies with the Category A are approved for coverage of routine services only. Studies with the Category B are approved for coverage of the Category B device and related services, and routine services.

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Study Title Sponsor Name NCT Number IDE Number CMS Approval Date Category
Medtronic Resolute Onyx Core (2.25 mm - 4.0 mm) Clinical Study Medtronic Vascular NCT02419521 G140178 07/02/2015 B
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2) Veryan Medical Ltd. NCT02400905 G140182 06/29/2015 B
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae C. R. Bard NCT02440022 G150067 06/17/2015 B
The Asahi Intecc PTCA Chronic Total Occlusion Study Asahi Intecc USA Inc NCT02379923 G150007 06/04/2015 B
Resolute Onyx 2.0 mm Clinical Study - A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Medtronic Vascular NCT02412501 G140178 05/14/2015 B
Zenith® p-Branch® Pivotal Study Cook Incorporated NCT02396199 G120136 05/06/2015 B
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components Cerus Corporation NCT0230573 BB6200 05/05/2015 B
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-V) Biotronik, Inc. NCT02389946 G140078 04/17/2015 B
Endurant Evo US Clinical Trial Medtronic Endovascular NCT02393716 G150024 04/17/2015 B
Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System STRYKER NCT02340585 G150006 04/14/2015 B
HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt OrbusNeich NCT02073565 G140118 04/01/2015 B
Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System Volcano Corporation NCT02394912 G140194 04/01/2015 B
Clinical Evaluation of the Lenstec SBL-3 Multifocal Intraocular Lens Lenstec Incorporated NCT02487160 G140134 07/28/2015 B
Phase II, Single Center, Single Arm, Open Label Investigation of Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams South Florida Medical Imaging, PA NCT02396420 G140213 07/28/2015 B
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms W.L.Gore & Associates NCT02489539 G150057 08/05/2015 B
Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II) Thoratec Corporation NCT02468778 G150079 08/17/2015 B
Analysis of Revascularization in Ischemic Stroke with EmboTrap® (ARISE II). Neuravi® Inc., NCT02488915 G140253 08/17/2015 B
Pyrocarbon IDE Study Tornier, Inc. NCT02525783 G140202 09/23/2015 B
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads Biotronik SE & Co. KG NCT02290028 G150147 09/21/2015 B
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions Nitiloop Ltd. NCT02477579 G150032 09/23/2015 B
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries (TOBA II) Intact Vascular NCT02522884 G150029 09/23/2015 B
The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant) Active Implants NCT02483988 G150052 09/28/2015 B
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation SentreHEART, Inc. NCT02513797 G150107 09/29/2015 B
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an Investigational Device Exemption (IDE) Study St. Jude Medical NCT02548455 G150175 09/29/2015 B
A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries Boston Scientific Corporation NCT02574481 G150171 10/28/2015 B
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery CytoSorbents, Inc NCT02566525 G140256 11/12/2015 B
Electrical Nerve Stimulation of the Ulnar Nerve During Cubital Tunnel Decompression Surgery: Does it Improve Long Term Functional Outcomes? University of Chicago NCT02566616 G150054 11/10/2015 B
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial) BioCardia, Inc. NCT02438306 BB16057 11/18/2015 B
Prostate Artery Embolization Safety and Efficacy: A Pilot Study University of Virginia NCT02592473 G150021 11/24/2015 B
Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System (CLIRST III) Cesca Therapeutics, Inc. NCT02538978 BB16266 11/24/2015 B
Clinical Evaluation of a Vascular Anastomotic Connector System for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis Phraxis, Inc. NCT02532621 G140221 12/15/2015 B
Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 Gregory W Albers NCT02586415 G150028 12/04/2015 B
EVOLVE Short DAPT Study Boston Scientific Corporation NCT02605447 G150194 12/18/2015 B
Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee Orthofix Inc. NCT02436590 G140251 12/30/2015 B
Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment Medical University of South Carolina NCT02535572 G150034 12/30/2015 B
REDUCE LAP-HF Randomized Trial I Corvia Medical, Inc. NCT02600234 G150210 01/13/2016 B
Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis Rodney A. White, M.D. NCT02524834 G150087 01/20/2016 B
Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE) CeloNova BioSciences, Inc. NCT02594501 G130190 01/25/2016 B
SSO2 therapy: IC-HOT study a multi-center evaluation of the delivery of intracoronary hyperoxemic supersaturated oxygen therapy for 60 minutes in anterior acute myocardial infarction patients with successful reperfusion (via PCI) ≤ six hours after symptom onset TherOx, Inc NCT02603835 G120029 2016-02-04 A
The BARD® VENOVO ™ Venous Stent Study – A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease – an Assessment for Effectiveness and Safety (VERNACULAR) Bard Peripheral Vascular NCT02655887 G150248 2016-02-09 B
Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men SRS Medical NCT02643849 G150243 2016-02-16 B
The CarboClear Pedicle Screw System Carbo-Fix Orthopedics Inc. NCT02626624 G150139 02/26/2016 B
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation CyberHeart Inc. NCT02661048 G130270 02/29/2016 A
Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set Stanford University NCT02687256 G150256 03/08/2016 A
Valiant Evo US Clinical Trial Medtronic NCT02652949 G150251 03/09/2016 B
Clinical Study of the BreathID® System to train the algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings of Non-Alcoholic Fatty Liver Disease (NAFLD) Exalenz Bioscience NCT02314026 G140254 03/17/2016 B
A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery. Baxter Healthcare Corporation NCT02640235 G130173 04/05/2016 B
Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres Sergei Sobolevsky NCT02679430 G140130 04/05/2016 B
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients (RESCUE) Mt. Sinai NCT01747837 G150050 2016-04-12 A
Self-Centering Guide Catheter Feasibility Study Boston Scientific Corporation NCT02639494 G150260 2016-04-13 B
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation Mitralign, Inc. NCT02574650 G150170 2016-04-12 A
Silver Nitrate-Coated Indwelling Pleural Catheter (SNCIPC) CareFusion, Inc. NCT02649894 G150146 S001 04/13/2016 A
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction (Athena) Mentor Worldwide NCT02724371 G150173 04/18/2016 B
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV (COMPASSION S3) Edwards Lifesciences NCT02744677 G150220 05/04/2016 B
A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease Ra Medical Systems NCT02653456 G150154 05/04/2016 B
Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology StimGuard NCT02434874 G150047 05/18/2016 B
Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure. Terumo CVS NCT02724072 G150224 05/18/2016 B
A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation in Patients With Relapsed Lymphoma Peiman Hematti NCT02652468 BB16328 05/25/2016 B
FlowTriever Pulmonary Embolectomy Clinical Study Inari Medical NCT02692586 G160002 05/17/2016 B
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Caisson Interventional, LLC NCT02768402 G160055 06/06/2016 A
Adjunctive Renal Denervation to Modify Hypertension and Sympathetic Tone as Upstream Therapy in the Treatment of Atrial Fibrillation Boston Scientific, Vivek Reddy, MD NCT01635998 G150161 06/06/2016 A
A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping NOVADAQ NCT02209532 G150254 06/06/2016 B
A Multicenter Randomized Controlled Trial to Compare the Efficacy of Ex-vivo Normothermic Machine Perfusion With Static Cold Storage in Human Liver Transplantation OrganOx, Ltd. NCT02775162 G140243 06/09/2016 B
Intrepid Transcatheter Mitral Valve Replacement System Medtronic NCT02322840 G160020 06/23/2016 A
Evaluation of WIRION™ EPS in Lower Extremities Arteries Gardia Medical, Ltd. NCT02780349 G160081 06/23/2016 B
COVERA Vascular Covered Stent Bard Peripheral Vascular NCT02649946 G160001 06/23/2016 B
Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure CVRx NCT02627196 G120010 06/23/2016 B
One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-Tate Temporary Implantable Nitinol Device (TINDTM) in Subjects With Benign Prostatic Hypertrophy (BPH). Medi-tate Ltd NCT02145208 G150068 06/29/2016 B
Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial) Microvention-Terumo, Inc. NCT02657707 G140249 07/07/2016 B
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD) Boston Scientific NCT02787785 G160074 07/11/2016 B
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures Boston Scientific Corporation NCT02802020 G150185 2016-07-20 B
Covera Vascular Covered Stent Bard Peripheral Vascular, Inc. NCT02790606 G160109 2016-07-22 B
Zoll 731 Series Ventilator with Fio2 Closed-Loop Control (CLC) Zoll Medical Corporation NCT02810080 G150245 2016-07-22 A
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS) University of Minnesota - Clinical and Translational Science Institute NCT02709148 G150273 2016-07-15 B
Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (OSPREY ILIAC) Terumo Medical Corporation NCT02793492 G160035 2016-07-13 B
Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH SF Catheter Evaluated for Treating Symptomatic Persistent AF (PRECEPT) Biosense Webster, Inc NCT02817776 G140102 2016-08-03 B
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair NeoChord NCT02803957 G160067 08/08/2016 B2
13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure William Lee NCT02786836 G150226 08/09/2016 B4
A Pilot Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults With Down Syndrome and Obstructive Sleep Apnea Massachusetts Eye and Ear Infirmary NCT02344108 G140209 08/16/2016 B
Evaluation of the TULSA-PRO MRI-guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer Profound Medical Inc. NCT02766543 G130103 08/23/2016 B
A Pilot, Prospective, Randomized, Controlled, Multicenter Technical Feasibility Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant Cohera Medical, Inc. NCT02841891 G160120 08/23/2016 A
Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients Cochlear Americas NCT02698787 G150140 09/01/2016 B
GDS Accucinch Ventriculoplasty System Guided Delivery Systems, Inc. NCT02806570 G150249 09/12/2016 A
Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries Biom'Up SA NCT02780869 G160063 08/10/2016 B
Monovisc Anika Therapeutics, Incorporated NCT02698865 G150131 09/12/2016 B
Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness Advanced Bionics NCT02189798 G140019 09/12/2016 B
Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Novocure NCT02831959 G160089 09/12/2016 B
CorMatrix ECM Tricuspid Valve Replacement Safety and Early Feasibility CorMatrix NCT02397668 G150019 09/15/2016 A
JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery Midwest Cardiovascular Research Foundation NCT02730234 G160015 09/19/2016 B
The WhiteSwell System: WhiteSwell Bloodline, WhiteSwell Console, WhiteSwell Catheter Boston Biomedical Associates, LLC. NCT02863796 G160083 10/03/2016 A
Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the INSPIRIS RESILIA Pulmonary Valve (Model 11500P) for Pulmonary Valve Replacement Edwards Lifesciences NCT02656290 G120108 10/13/2016 B
Multi-center, Prospective, Randomized, Controlled Clinical Trial Study of Chronic Tibial Nerve Stimulation (CTNS) to Demonstrate Non-Inferiority in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB) With Wireless Neuromodulation Technology as Compared to Peripheral Tibial Nerve Stimulation (PTNS) - "PROTECT" Study StimGuard, LLC. NCT02577302 G150178 10/19/2016 B
Pivotal Clinical Study to Evaluate the Safety and Effectiveness of MANTA Vascular Closure Device Essential Medical, Inc. NCT02908880 G160115 10/25/2016 B
Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor University of Florida NCT02649166 G160053 10/31/2016 B
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients, SOLVE CRT EBR Systems, Inc. NCT02922036 G150244 11/01/2016 B
Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study LifeBond Ltd. NCT02907385 G150157 11/08/2016 B
Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma Sight Sciences, Inc. NCT02928289 G160064 11/08/2016 B
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US SoniVie Ltd. NCT02835950 G160110 11/17/2016 A
Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH) Rhode Island Hospital NCT02676544 G150192 11/17/2016 B
A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions TriReme Medical, LLC NCT02924857 G160085 11/23/2016 B
Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System® Intact Vascular NCT02942966 G160144 12/05/2016 B
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears InGeneron, Inc. NCT02918136 BB16956 12/05/2016 B
A Feasibility Study of Sequential Hepatic Internal Radiation and Systemic Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastatic to Liver. David Minor, MD NCT02913417 G150186 12/05/2016 B
International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial) TransMedics NCT02522871 G140192 12/20/2016 B
Ovation Alto Abdominal Stent Graft System Endologix, Inc. NCT02949297 G160226 01/23/2017 B
Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia Terumo BCT Biotechnologies NCT02964325 BB16116 01/23/2017 B
Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors) Duke/ Medtronic/Terumo/Volcano NCT02939976 G160113 01/31/2017 B
A Prospective, Randomized Multicenter Controlled Trial of CERAMENT™|G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures BONESUPPORT NCT02820363 G160150 02/01/2017 B
Phase II Trial Of Optune Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma NovoCure Ltd. NCT02743078 G150275 01/10/2017 B
A Traditional Feasibility Study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma Medical University of South Carolina NCT02512692 G150096 01/10/2017 B
A Prospective, Multicenter Clinical Trial of the Implantable Miniature Telescope in Pseudophakic Eyes With Central Vision Impairment Associated With End-Stage Macular Degeneration. VisionCare, Inc. NCT03011554 G160121 02/06/2017 B
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study Medtronic Cardiovascular NCT02979587 G120175 02/07/2017 B
Gore CARDIOFORM ASD Occluder W.L.Gore and Associates, Inc.-GORE® NCT02985684 G160218 02/10/2017 B
MASTER GE Healthcare NCT02972892 G160132 02/21/2017 B
Mitral Valve Repair Clinical Trial (MAVERIC Trial) Mvrx, Inc. NCT02302872 G160098 02/23/2017 A
LEADERS FREE II: BioFreedom Pivotal Study Biosensors Europe SA NCT02843633 G130034 2017-03-07 B
A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) – RANGER II SFABoston Scientific Corp. Boston Scientific Corp. NCT03064126 G160172 2017-03-02 B
Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms BioVentrix NCT02931240 G160013 03/09/2017 B
A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle Ferring Pharmaceuticals NCT03028415 G150153 03/15/2017 A
IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter Medtronic Vascular, Inc. NCT03041467 G160242 03/20/2017 B
Prostate Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia University of California, San Diego NCT03055624 G160214 03/21/2017 B
A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System Premia Spine NCT03012776 G160168 03/02/2017 B
Artisse Intrasaccular Device Medtronic NCT02998229 G160213 03/20/2017 B
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) University of Minnesota - Clinical and Translational Science Institute NCT02930889 G160004 04/03/2017 B
Da Vinci SP Surgical System, Endowrist SP Instruments, and Accessories Intuitive Surgical, Inc. NCT03049280 G160251 04/04/2017 B
STOP Persistent AF Medtronic Atrial Fibrillation Solutions NCT03012841 G160177 04/17/2017 B
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study ABIOMED NCT03000270 G160197 04/14/2017 B
Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA) University of Michigan NCT03065647 G160263 04/14/2017 B
Aluvra Impleo Medical, Inc. NCT03090607 G160238 04/24/2017 B
Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy InGeneron, Inc. NCT02961699 BB17214 04/26/2017 B
Impact of Fever Prevention in Brain Injured Patients C. R. Bard NCT02996266 G160108 04/18/2017 B
Abre Venous Self-Expanding Stent System Medtronic NCT03038438 G160163 05/03/2017 B
Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Osteomas Matthew Bucknor NCT02923011 G160266 05/03/2017 B
TECNIS Next-Generation Intraocular Lens, Models ZHR00 and ZQR00 Abbott Medical Optics Inc. NCT03111550 G170055 05/10/2017 B
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization Rex Medical NCT02961894 G160267 2017-05-10 B
Corvia Medical Interatrial Shunt Device (IASD) System II Corvia Medical, Inc. NCT03088033 G150210 05/10/2017 B
Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters. OrbusNeich NCT03052530 G170007 04/24/2017 B
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial Washington University School of Medicine NCT03052920 G140244 05/26/2017 B
A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions Medtronic Spinal and Biologics NCT03118505 G160139 05/26/2017 B
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II PROCEPT BioRobotics NCT03123250 G170027 06/05/2017 B
Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA) The Christ Hospital NCT03111459 G170036 06/05/2017 B
Deep Brain Stimulation to Relieve Depression University of Pittsburgh NCT02889250 G160025 06/08/2017 B
RELIEF Study: A Prospective, Multicenter Study of REflux Management With the LINX® System for Gastroesophageal REFlux Disease After Laparoscopic Sleeve Gastrectomy Torax Medical Incorporated NCT02429830 G160170 06/06/2017 B
STOP AF First: Cryoballoon Catheter Ablation in an Antiarrhythmic Drug Naive Paroxysmal Atrial Fibrillation Medtronic Atrial Fibrillation Solutions NCT03118518 G160219 06/06/2017 B
Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure Cardiac Dimensions Pty Ltd NCT03142152 G160223 06/06/2017 B
Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP) St. Joseph's Hospital and Medical Center, Phoenix NCT02513914 G160232 06/22/2017 B
Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK) University of Chicago NCT03141255 G160183 06/22/2017 B
Medtronic TAAA Debranching Stent Graft System Vanderbilt University Medical Center NCT03113383 G160182 06/22/2017 B
Cardioband Mitral System Edwards Lifesciences Corporation NCT03016975 G160246 06/22/2017 B
Attain Stability™ Quad Clinical Study Medtronic Cardiac Rhythm and Heart Failure NCT03099655 G170020 06/22/2017 B
Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders University of Colorado, Denever NCT03093844 BB17240 07/07/2017 B
Multicenter Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcather Heart Valve With the Alterra Adaptive Prestent Edwards Lifesciences NCT03130777 G170053 07/21/2017 B
Cardiva Mid-Bore Venous Vascular Closure System (VVCS) Cardiva Medical, Inc. NCT03193021 G170144 08/03/2017 B
Evaluation of the Surfacer System Approach to Central Venous Access Bluegrass Vascular Technologies NCT03209050 G170045 08/03/2017 A
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST) University of Texas Southwestern Medical Center NCT03191058 G170127 08/03/2017 B
A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support Vascular Graft Solutions Ltd. NCT03209609 G150225 08/10/2017 B
Prospective, Randomized, Double-Blinded, Controlled Multi-Center Clinical Trial Evaluating the Use of Non-Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures Encore Medical, L.P. NCT02688855 G150262 08/10/2017 B
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) Alcon Laboratories, Inc. NCT03170154 G170112 08/10/2017 B
An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies OncoSil Medical Limited NCT03076216 G150271 08/17/2017 B
A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery Bolton Medical NCT03214601 G160237 08/18/2017 A
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study Svelte Medical Systems, Inc. NCT03190473 G160227 08/18/2017 B
A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes Sino Medical Sciences Technology Inc. NCT03168776 G160235 08/22/2017 B
XIENCE Short DAPT Study Abbott Vascular NCT03218787 G170081 08/24/2017 B
PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve Edwards Lifesciences NCT03193801 G150278 08/25/2017 B
Epidural Stimulation for Spinal Cord Injury University of Minnesota - Clinical and Translational Science Institute NCT03026816 G160247 08/30/2017 B
A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo Aspiration System in Acute Submassive Pulmonary Embolism Penumbra Inc. NCT03218566 G170064 09/08/2017 B
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant KeraMed, Inc. NCT03126903 G150267 09/08/2017 A
Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms University of Colorado, Denver NCT02989948 G160207 09/08/2017 B
Safety and Effectiveness Evaluation of Eximo Medical's B-LaserTM, a Hybrid Atherectomy Device, in Subjects Affected with Infrainguinal PAD Eximo Medical Ltd NCT03157531 G170104 09/20/2017 B
The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon SurModics, Inc. NCT03241459 G150121 10/03/2017 B
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms New York University School of Medicine NCT03246126 G170048 09/12/2017 B
INSIGHT: EvaluatIoN of the PantheriS OCT- ImaGing AtHerectomy SysTem For Treatment of In-Stent Restenosis (ISR) Lesions In Lower Extremity Arteries Avinger, Inc. NCT03192696 G170078 10/03/2017 B
Intrepid Transcatheter Mitral Valve Replacement System Medtronics NCT03242642 G160020 09/26/2017 B
Deep Brain Stimulation (DBS) in Patients With Refractory Chronic Neuropathic Pain University of California, San Francisco NCT03029884 G160018 10/11/2017 A
AcrySof®IQ Extended Depth of Focus (EDF) Intraocular Lens (IOL) Alcon Research, Ltd. NCT03274986 G170175 10/12/2017 B
Theranova 400 Dialyzer Baxter Healthcare Corporation NCT03257410 G170157 10/11/2017 B
Randomized Trial Of Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention Emilia Bagiella NCT03089398 G170154 09/22/2017 B
Proposed Single Center Investigational Device Exemption: Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis Rodney A. White, M.D. NCT02524834 G150087 10/23/2017 B
Intravascular Ventricular Assist System (iVAS) NuPulseCV, Inc. NCT02645539 G150242 10/23/2017 B
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study (SITRAL) Baylor Research Institute NCT02830204 G160024 2017-10-16 B
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (SIRCCA) Sirtex Medical NCT02807181 G160128 2017-10-26 B
AcrySof IQ PanOptix Intraocular Lens Alcon Research, Ltd. NCT03280108 G170172 2017-10-26 B
SAPIEN M3 System Edwards Lifesciences LLC NCT03230747 G170152 10/26/2017 A
Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE) Evalve NCT03227757 G170118 11/07/2017 A
The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury University of Utah NCT03083366 G160136 11/06/2017 B
Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR) Vivek Reddy NCT03263702 G170049 11/10/2017 B
A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support Alung Technologies NCT03255057 G170096 10/31/2017 B
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System Edwards Lifesciences NCT02471807 G150041 01/11/2017 A
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula Laminate Medical Technologies NCT03242343 G170039 11/24/2017 B
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms University of South Florida NCT03075748 G170024 11/28/2017 B
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias Vivek Reddy NCT03204981 G170067 12/15/2017 B
Evaluate the Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood Compared With Conventional RBCs in Patients Requiring Chronic Transfusion Support Terumo BCTbio NCT03329404 BB15025 12/12/2017 A
A Randomized Controlled Clinical Evaluation of the DiamondTemp™ System for the Treatment of Paroxysmal Atrial Fibrillation Advanced Cardiac Therapeutics NCT03334630 G170227 12/22/2017 B
TSolution One® Total Knee Arthroplasty Clinical Trial Think Surgical Inc. NCT03017261 G160094 12/22/2017 B
RCStim Model 1114R or 1114L Soft Tissue Stimulator Orthofix, Inc. NCT03339492 G170147 01/02/2018 B
Pilot Study to Examine the Feasibility of the DISCSS™ Meagan Medical NCT03341000 G170169 01/03/2018 B
Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease Eminence Clinical Research, Inc. NCT03301246 G170090 01/08/2018 B
Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping Vivek Reddy NCT03349476 G170110 01/10/2018 B
Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation Abbott NCT03354663 G170245 01/10/2018 B
TECNIS® Next-Generation Intraocular Lenses (IOLs), Models ZFR00 and ZYR00 Abbott Medical Optics Inc. NCT03372434 G170243 01/19/2018 A
Panoramic ECGi to Guide Ablation of Non-Paroxysmal AF: Effect of Ibutilide on AF Source Location and Organization Vivek Reddy NCT03370536 G170065 01/26/2018 B
A Prospective, Multi-Center, Randomized Concurrently Controlled Trial to Evaluate the Safety and Effectiveness of the Altum® Pedicle Osteotomy System for Use in Lumbar Spinal Stenosis Innovative Surgical Designs NCT03381677 G110179 01/26/2018 A
Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis Mayo Clinic NCT03269409 BB17455 01/26/2018 B
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial) CytoSorbents, Inc NCT03384875 G140256 02/02/2018 A
Clinical Study Protocol for the Investigation Of The Two Level Simplify® Cervical Artificial Disc Simplify Medical Inc. NCT03123549 G150206 02/02/2018 B
JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER) Midwest Cardiovascular Research Foundation NCT03206762 G170066 02/08/2018 B
LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure NovoCure Ltd. NCT02973789 G170238 02/15/2018 A
Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study Edwards Lifesciences NCT03382457 G170284 02/15/2018 A
Hemodynamic-GUIDEd Management of Heart Failure Abbott NCT03387813 G170258 02/23/2018 B
A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm Pulsar Vascular NCT03383666 G170220 02/27/2018 A
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial Washington University School of Medicine NCT03250247 G170161 02/27/2018 B
MED-EL SYNCRONY Cochlear Implant System MED-EL Corporation NCT03236909 G170111 03/15/2018 B
Metabolic Mapping and Cardiac Resynchronization (Aim 1) Yong-Mei Cha NCT03420833 G150177 03/14/2018 B
PQ Bypass System for Femoropopliteal Bypass II PQ Bypass, Inc. NCT03119233 G170083 03/23/2018 B
Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation TransMedics NCT03343535 G130019 03/23/2018 B
Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor University of Florida NCT03051178 G170302 04/04/2018 A
Local Field Potential (LFP) Beta Adaptive Deep Brain Stimulation (aDBS) Feasibility Study MedtronicNeuro NCT03446833 G170191 04/04/2018 B
GORE PV1 Device W. L. Gore & Associates NCT03441971 G170289 04/04/2018 A
Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma NovoCure Ltd. NCT03377491 G170288 04/04/2018 A
P-15L Bone Graft Cerapedics, Inc. NCT03438747 G170300 04/12/2018 B
Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery FzioMed NCT03433391 G170195 04/12/2018 B
MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage Penumbra Inc. NCT03342664 G170129 04/27/2018 B
Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults Cochlear NCT03007472 G160256 05/05/2017 B
INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH) J. Mocco NCT02654015 G150222 04/27/2018 B
Safety and Feasibility of Adipose Derived Regenerative Cells (ADRCs) in the Treatment of Deep Partial Thickness and Full Thickness Thermal Wounds (RELIEF) Cytori Therapeutics NCT03435172 BB17234 04/27/2018 B
INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry J. Mocco NCT02661672 G150222-1 04/27/2018 B
Treatment With Intent to Generate Endovascular Reperfusion Rapid Medical NCT03474549 G180004 05/01/2018 B
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial) BioCardia, Inc. NCT03455725 BB17905 05/02/2018 B
EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s) Boston Scientific Corporation NCT03350542 G170282 05/07/2018 B
Tendyne Mitral Valve System Abbott NCT03433274 G140240 05/08/2018 B
A Multi-Center, Prospective Clinical Trial To Evaluate The Safety And Effectiveness of the CT LUCIA 611p Posterior Chamber Intraocular Lens For Correction of Aphakia Following Cataract Removal Carl Zeiss Medictec Production, LLC NCT03451786 G170266 05/21/2018 A
A Validation of the Assisted Fluid Management Feature Edwards Lifesciences NCT03469570 G170204 05/22/2018 A
A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients With ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9) Population Health Research Institute NCT03048825 G170179 05/23/2018 B
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study St. Jude Medical NCT03490201 G170221 05/23/2018 B
A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries ReFlow Medical, Inc. NCT03403426 G170251 03/13/2018 B
A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents Boston Scientific Corporation NCT03525808 G170261 06/08/2018 B
Evaluation of the Tissue Genesis Icellator Cell Isolation System to Treat Erectile Dysfunction Tissue Genesis, LLC NCT03518333 BB14861 06/15/2018 B
LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study University of North Carolina, Chapel Hill NCT03372096 G170232 06/15/2018 B
The Mount Sinai Diabetic Foot Ulcer Prospective Trial Windsor Ting NCT03404895 G170254 06/15/2018 B
OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI St. Jude Medical NCT03507777 G180052 06/21/2018 B
Next-Generation TECNIS Symfony Extended Range of Vision IOL Johnson & Johnson Surgical Vision, Inc. NCT03500198 G180044 6/21/2018 B
ROBUST III - Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease - A Randomized Control Trial Urotronic Inc. NCT03499964 G180041 06/21/2018 B
PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas Microvention-Terumo, Inc. NCT03467542 G170203 06/27/2018 B
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