ROADSTER 3 Extended Follow-up Sub-Study

Stopped early

Conditions studied: Carotid Artery Diseases

In brief

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).

Key facts

Study ID

NCT06470815

Run by

Silk Road Medical

People needed

197

Starts

2024-07-31

Expected to finish

2025-12-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
• Able to provide informed consent

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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