Health Trials

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 103
Trial details
Age: 18-82Biological sex: AllType: InterventionalSponsor: InspireMDUpdated: Dec 11, 2025
Eligibility criteria

Patient is willing and able to provide appropriate study-specific informed conse...

Patient had or will have an interventional procedure or surgery of the carotid,... [+10]

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Status: Recruiting

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

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.

Participants needed: 50
Trial details
Age: 18-79Biological sex: AllType: InterventionalSponsor: InspireMDUpdated: May 31, 2025Locations: 8
Eligibility criteria

Patient is ≥ 18 years and < 80 years of age. [+29]

Patient had or will have an interventional procedure or surgery of the carotid,... [+32]

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