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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
Inclusion Criteria
  • Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
  • Able to provide informed consent
Exclusion Criteria
  • 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
NameTimeMethod
In-stent Restenosis2-years and 5-years following the index procedure

In-stent restenosis ≥70% at 2-years and 5-years

Ipsilateral Stroke Mortality2-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 Stroke2-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
NameTimeMethod

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

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