ROADSTER 3 Extended Follow-up Sub-Study
- Conditions
- Carotid Artery Diseases
- 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
- 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)
Atrium Health
🇺🇸Charlotte, North Carolina, United States
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
Scroll for more (27 remaining)Atrium Health🇺🇸Charlotte, North Carolina, United States