CGUARDIANS III IDE Pivotal Trial

This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery Revascularization procedures using the CGuard Prime Carotid Stent System 80 in the treatment of carotid artery stenosis in patients at high risk for complications from CEA.

NCT Number	NCT07277296
Lead Sponsor	InspireMD
Conditions	Carotid Artery Stenosis
Enrollment	103 participants
Start Date	2026-01-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-11