Not Yet RecruitingNot Applicable

CGUARDIANS III IDE Pivotal Trial

103 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range18 Years – 82 Years

SexALL

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Inclusion criteria

✓. Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
✓. Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:
✓. High Risk condition for CEA: at least one, as shown below:

Exclusion criteria

✕. Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure
✕. Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure
✕. Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
✕. Previously placed stent in the ipsilateral ICA or CCA
✕. Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA
✕. Presence of a filling defect of the target lesion
✕. Tandem lesions, which cannot be covered by a single CGuard Prime stent
✕. Stenosis of the innominate artery or proximal CCA requiring revascularization

What they're measuring

Composite primary endpoint

Timeframe: 30 days

Trial details

NCT IDNCT07277296

SponsorInspireMD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

InspireMD HCC

(800) 831-7819 HCC@hartclinicalconsultants.com

View on ClinicalTrials.gov More Carotid Artery Stenosis trials