NCT07277296

CGUARDIANS III IDE Pivotal Trial

A Multicenter, Single-arm, Pivotal Study to Evaluate the Safety and Efficacy of the SwitchGuard™ Neuroprotection System (NPS) for Providing Cerebral Embolic Protection During Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach When Used in Conjunction With the CGuard™ Prime 80 Carotid Stent System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: InspireMD · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a prospective, multi-center, single arm pivotal study. The study shall not be blinded prior to, during or following the procedure. Patients undergoing transcarotid artery revascularization will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provided informed consent and shall subsequently be assigned a study ID number. Enrollment will be 103 pivotal patients. A maximum of 20% of patients will be enrolled at any single site. The total enrollment accounts for an estimate that up to 2 patients will exit the study prior to the 30-day primary endpoint assessment. An additional roll-in cohort of up to 2 patients per primary physician operator at each study site may also be accrued (maximum of 50 roll-in patients total, assuming one primary physician operator per site). This study does not duplicate any current knowledge existing today on use of the SwitchGuard NPS when used in conjunction with the CGuard Prime™ 80cm in the United States.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	SwitchGuardTM NPS	The CGuard Prime™ 80 will be used in conjunction with the SwitchGuard™ NPS for the carotid artery stenting implantation procedure that will be performed by physician investigators experienced with transcarotid artery revascularization.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-12-11
• Last updated: 2025-12-11

Regulatory

• FDA-regulated device study