Carotid Artery Stenting (CAS) Investigational Studies

The Percutaneous Transluminal Angioplasty (PTA) National Coverage Determination (NCD) covers carotid artery stenting (CAS) procedures under certain circumstances including through study participation.  Listed below are the investigational studies covered under sections B2 and B3 of this NCD.

Note: Effective 10/11/2023, section B4 of NCD 20.7 covers a broader patient population, some of which may continue to be involved in investigational studies. When CAS procedures are performed as part of an investigational study under section B2 or B3, the study protocol must be followed. 

Registry Approvals

CREST-2 Registry (C2R)
Clinicaltrials.gov number:  NCT02240862
http://clinicaltrials.gov/ct2/show/NCT02240862?term=C2R&rank=1
CMS Approval Date:  09/17/2014

Clinical Study Approvals

Study Title: The ROADSTER 3 Study
Sponsor:  Silk Road Medical
Clinicaltrials.gov number:  NCT05365490
Premarket Approval (PMA) number:  P140026
CMS Approval Date:  04/28/2022

Study Title: SVS VQI TransCarotid Revascularization Surveillance Project (VQI-TCAR)
Sponsor: Society for Vascular Surgery
Clinicaltrials.gov number: NCT02850588
CMS Approval Date: 09/01/2016

Study Title: ROADSTER 2 Registry
Sponsor:  Silk Road Medical
Clinicaltrials.gov number:  NCT02536378
Premarket Approval (PMA) number:  P140026
CMS Approval Date:  08/03/2015

Study Title:  Carotid Revascularization for Primary Prevention of Stroke (CREST-2)
Sponsor:  National Institute of Neurological Disorders and Stroke (NINDS)
Clinicaltrials.gov number:  NCT02089217
Investigational Device Exemption (IDE) number:  G130221
CMS Approval Date:  09/17/2014