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ROADSTER 3 Extended Follow-up Sub-Study

NCT06470815 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2026-05-19

No results posted yet for this study

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).

Conditions

  • Carotid Artery Diseases

Interventions

PROCEDURE

Transcarotid Artery Revascularization (TCAR)

Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Sponsors & Collaborators

  • Silk Road Medical

    lead INDUSTRY

Principal Investigators

  • Meghan Dermody, MD · Lancaster General Hospital

  • Jeffrey Jim, MD · Abbott Northwestern Minneapolis Heart Institute Foundation

  • Marc Schermerhorn, MD · Beth Israel Deaconess Medical Center

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470815 on ClinicalTrials.gov