~54 spots leftby Mar 2026

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

Palo Alto (17 mi)
William A. Gray, MD | Main Line Health
Overseen byWilliam A Gray, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
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 have a diagnosed blockage in my neck artery, either with symptoms at 50% blockage or without symptoms at 80% blockage.
I have a narrowed carotid artery and am at high risk for surgery.
I am a man or a woman not pregnant or breastfeeding, aged 20 to 80.
I have a single new or recurring blockage in my carotid artery that can be treated with one stent.

Exclusion Criteria

My blood vessels are too twisted or hardened for safe device insertion.
My tests show a blood clot in the artery of my neck.
My kidney function is low (creatinine ≥ 2.5 or GFR < 30).
I have a neurological condition that is not caused by a stroke.
I have or am suspected to have COVID-19.
I have not had a heart attack in the last 14 days.
I have had a severe stroke that left me with significant disabilities.
I cannot take standard medications like aspirin due to health reasons.
I have a history of irregular heartbeats needing long-term blood thinners.
My doctor expects I have less than a year to live due to my cancer spreading, and I am currently on chemotherapy or need an organ transplant.
I have heart or blood clot issues that could cause blockages.
I do not have conditions that make certain heart tests or procedures unsafe.
My carotid artery narrowing is not due to hardening of the arteries.
I have a severe blockage in my artery that is not the main one being treated.
I currently have a fever above 100.4F or an active infection.
I am currently experiencing a stroke.
I cannot have needle-based procedures due to severe blood vessel issues.
I have a bleeding disorder or can't take enough heparin to prevent clots.
I have a moving clot or plaque in my heart's main artery.
My aorta has a Type III arch.

Treatment Details

The 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.
1Treatment groups
Experimental Treatment
Group I: Carotid artery stentingExperimental Treatment1 Intervention
Carotid artery stenting procedure with Neuroguard IEP System

Find a clinic near you

Research locations nearbySelect from list below to view details:
St. Francis HospitalRoslyn, NY
UNC Rex HospitalRaleigh, NC
University of Buffalo NeurosurgeryBuffalo, NY
Huntsville HospitalHuntsville, AL
More Trial Locations
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Who is running the clinical trial?

Contego Medical, Inc.Lead Sponsor
Yale Cardiovascular Research GroupCollaborator
Advance Research AssociatesCollaborator
CardioMed Device Consultants, LLCIndustry Sponsor
Iqvia Pty LtdIndustry Sponsor
Medidata SolutionsIndustry Sponsor

References