Clinical Trial

A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach

Recruiting
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Summary
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-20; most recent amendment 2025-05-30.
Status change: Not Yet Recruiting → Recruiting 2025-02-12
Trial Details
NCT Number NCT06653387
Lead Sponsor InspireMD
Collaborators: Washington University School of Medicine, TriHealth Inc., NAMSA
Conditions Carotid Artery Diseases
Enrollment 50 participants
Start Date 2024-11-20
Primary Completion 2026-11-20 (estimated)
Study Completion 2027-11-20 (estimated)
Updated on ClinicalTrials.gov 2025-05-31