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ROADSTER 3 Extended Follow-up Sub-Study
Sponsor: Silk Road Medical
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).
Official title: Long-Term Follow-up Study of ROADSTER 3 Patients
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
OBSERVATIONAL
Enrollment
197
Start Date
2024-07-31
Completion Date
2025-12-31
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Transcarotid Artery Revascularization (TCAR)
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
Locations (37)
Valley Vascular Consultants
Huntsville, Alabama, United States
HonorHealth
Scottsdale, Arizona, United States
Pima Heart & Vascular
Tucson, Arizona, United States
University of California, San Diego (UCSD)
La Jolla, California, 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
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
New York University
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Providence Portland Medical Center-Hospital
Portland, Oregon, 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