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The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation

NCT03982420 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-01-14

Study results available
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Summary

The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.

Conditions

  • Carotid Artery Diseases
  • Carotid Atherosclerosis
  • Carotid Stenosis
  • Carotid Artery Plaque
  • Carotid Disease

Interventions

PROCEDURE

Transcarotid Revascularization (TCAR)

Carotid 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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2022-01-19
Completion
2022-01-19
FDA Device
Yes

Countries

  • United States
  • Spain

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 NCT03982420 on ClinicalTrials.gov