ROADSTER 3 Extended Follow-up Sub-Study
- Conditions
- Carotid Artery Diseases
- Interventions
- Procedure: Transcarotid Artery Revascularization (TCAR)
- Registration Number
- NCT06470815
- Lead Sponsor
- Silk Road Medical
- Brief Summary
The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).
- Detailed Description
This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 400
- Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
- Able to provide informed consent
- Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard-risk patients who underwent carotid intervention Transcarotid Artery Revascularization (TCAR) Symptomatic or asymptomatic patients with a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA), who underwent carotid artery revascularization.
- Primary Outcome Measures
Name Time Method In-stent Restenosis 2-years and 5-years following the index procedure In-stent restenosis ≥70% at 2-years and 5-years
Ipsilateral Stroke Mortality 2-years, 3-years, 4-years, and 5-years following the index procedure Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke 2-years, 3-years, 4-years, and 5-years following the index procedure Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Pima Heart & Vascular
🇺🇸Tucson, Arizona, United States
University of California, San Diego (UCSD)
🇺🇸La Jolla, California, United States
New York University
🇺🇸New York, New York, United States
Valley Vascular Consultants
🇺🇸Huntsville, Alabama, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Sharp Grossmont
🇺🇸La Mesa, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
AdventHealth Ocala
🇺🇸Ocala, Florida, United States
Northside Vascular
🇺🇸Cumming, Georgia, United States
Carle Health
🇺🇸Urbana, Illinois, United States
Deaconess Research / Evansville Surgical Associates
🇺🇸Evansville, Indiana, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital
🇺🇸Lafayette, Louisiana, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
McLaren Heart & Vascular
🇺🇸Bay City, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Abbott Northwestern
🇺🇸Minneapolis, Minnesota, United States
St. Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The Mount Sinai Hospital
🇺🇸New York City, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
St. Luke's University Hospital
🇺🇸Bethlehem, Pennsylvania, United States
UPMC Pinnacle
🇺🇸Harrisburg, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
Memorial Hermann Southeast
🇺🇸Houston, Texas, United States
Houston Methodist Sugarland
🇺🇸Sugarland, Texas, United States
Sentara
🇺🇸Norfolk, Virginia, United States
Carilion Roanoke Memorial
🇺🇸Roanoke, Virginia, United States
Charleston Area Medical Center (CAMC)
🇺🇸Charleston, West Virginia, United States