This study is accepting new patients by invitation only

ROADSTER 3 Extended Follow-up Sub-Study

a study on Peripheral Artery Disease

Summary

Eligibility
for people ages 18-79 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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

Details

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.

Keywords

Carotid Artery Diseases, Long-term Follow-up, TCAR, Transcarotid Artery Revascularization (TCAR)

Eligibility

You can join if…

Open to people ages 18-79

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

You CAN'T join 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

Locations

  • University of California, San Diego (UCSD)
    La Jolla California 92037 United States
  • Sharp Grossmont
    La Mesa California 91942 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Silk Road Medical
ID
NCT06470815
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated