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 now · Not applicable
Conditions studied: Carotid Artery Diseases
In brief
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.
Key facts
- Study ID
- NCT06653387
- Run by
- InspireMD
- People needed
- 50
- Starts
- 2024-11-20
- Expected to finish
- 2027-11-20
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC Davis Health — Sacramento, California, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Allina — Minneapolis, Minnesota, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Benefis Health System — Great Falls, Montana, United States (enrolling)
- Mount Sinai Hospital — New York, New York, United States (enrolling)
- University of Rochester — Rochester, New York, United States (enrolling)
- TriHealth — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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