Neuroguard IEP System for Carotid Artery Stenosis
(PERFORMANCE II Trial)

Recruiting in Palo Alto (17 mi)

+40 other locations

Overseen byWilliam A Gray, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Contego Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Neuroguard IEP System for people with significant narrowing of the carotid arteries. The device opens up the blocked artery, catches any loose particles, and keeps the artery open with a small tube. This group is targeted because they are at high risk for complications from traditional surgery.

Eligibility Criteria

This trial is for adults aged 20-80 with carotid artery stenosis who are at high risk for surgery. They must have a specific lesion size and location, be able to follow the study plan, and take dual antiplatelet therapy post-procedure. Pregnant or breastfeeding women, those with severe other illnesses, recent major surgeries or strokes, certain blood conditions, or known allergies to materials used in the procedure cannot participate.

Inclusion Criteria

My target lesion fits within the size limit for the stent.

The artery in my neck fits the required size for a stent.

I can follow the study rules and attend all visits, and I'm reachable by phone.

See 13 more

Exclusion Criteria

My blood vessels are too twisted or hardened for safe device insertion.

The target lesion in the artery is mostly blocked and has reduced blood flow.

My tests show a blood clot in the artery of my neck.

See 35 more

Treatment Details

Interventions

Carotid artery stenting with Neuroguard IEP System (Procedure)

Trial OverviewThe Neuroguard IEP System is being tested for its safety and effectiveness in treating carotid artery stenosis in patients who face high risks from traditional surgery. This single-arm study involves multiple centers where participants receive this particular stenting system.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Carotid artery stentingExperimental Treatment1 Intervention

Carotid artery stenting procedure with Neuroguard IEP System