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Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

NCT05365490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 344

Last updated 2025-07-30

No results posted yet for this study

Summary

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy

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
2022-09-01
Primary Completion
2025-07-22
Completion
2025-07-22
FDA Device
Yes

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 NCT05365490 on ClinicalTrials.gov