Roadsaver Stent + Nanoparasol for Carotid Stenosis

Palo Alto (17 mi)

Overseen byAdnan Siddiqui, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Microvention-Terumo, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a method to treat patients with narrowed neck arteries who are at high risk for surgery complications. The method keeps the artery open and catches debris to prevent strokes. A group of patients will be monitored over time to evaluate safety and effectiveness. These methods have been explored as alternatives to surgery, especially for high-risk patients.

Eligibility Criteria

This trial is for adults aged 21-80 with carotid artery stenosis who are at high risk for surgery. Eligible participants must have a lesion that can be treated with the Roadsaver™ stent, meet certain anatomical or health-related criteria indicating higher surgical risks, and agree to follow-up requirements. Exclusions include those with other potential emboli sources, atrial fibrillation, severe blood disorders, uncontrolled diabetes, recent major strokes or heart attacks, and women who are pregnant.

Inclusion Criteria

I have a narrowed carotid artery by at least 50% and symptoms, or it's narrowed by 80% without symptoms.

I have been diagnosed with a narrowing of my carotid artery and am considered high risk for surgery.

I have a single new or recurring blockage in my artery that can be treated with one stent.

I have a high-risk condition related to my anatomy or health that qualifies me.

My target lesion is located at the carotid bifurcation or proximal ICA.

I am between 22 and 80 years old.

My affected blood vessel is between 3.0 mm and 9.0 mm wide.

Exclusion Criteria

I have a condition that could cause blood clots, but I've been on blood thinners for at least two weeks.

I currently have an infection.

I have kidney failure or am on dialysis.

I have diabetes that is not well-controlled.

I have a significant narrowing in the artery opposite to the one being studied.

I have a disability that affects my daily activities, not caused by a stroke.

I cannot take standard medications, including those for blood thinning.

I have had a stroke in the last 30 days that has significantly affected my abilities.

I have severe kidney, liver issues, very high blood pressure, or am extremely overweight.

I have atrial fibrillation.

I have a bleeding disorder or am at high risk for blood clots, or I refuse blood transfusions.

Treatment Details

The study tests the safety and effectiveness of the Roadsaver™ Carotid Stent System used alongside the Nanoparasol® Embolic Protection System in patients with carotid artery stenosis. It's an observational study where all participants receive this combination treatment to see how well it works compared to traditional surgery.

1Treatment groups

Experimental Treatment

Group I: Single-arm, open labelExperimental Treatment2 Interventions

To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.