What side effects are associated with this type of intervention?

Common treatments for Carotid Artery Stenosis, such as stent placement and embolic protection systems, have several known side effects. Stent placement can lead to restenosis (re-narrowing of the artery) and arterial dissection (tearing of the artery wall). Embolic protection systems, while designed to prevent debris from causing blockages, can still result in complications like stroke, transient ischemic attack, and other embolic events. Other potential side effects include hematoma, bruising, and discomfort at the insertion site.

What prior FDA approvals exist?

The FDA has approved several treatments for Carotid Artery Stenosis, including stent placement and embolic protection systems. Notable approvals include the use of carotid artery stents, which are designed to open narrowed carotid arteries, and embolic protection devices that prevent debris from causing blockages during the procedure. These treatments aim to reduce the risk of stroke by ensuring that the blood flow to the brain is not obstructed by atherosclerotic plaque or procedural debris. The MicroVention, Inc. Roadsaver™ Carotid Stent System and the Nanoparasol® embolic protection system are examples of such advanced treatments currently under study.

What other types of research exist?

Promising alternatives to the MicroVention, Inc. Roadsaver™ Carotid Stent System and Nanoparasol® embolic protection system for carotid artery stenosis include the following: 1) The TCAR (TransCarotid Artery Revascularization) system, which combines direct carotid access with flow reversal to minimize embolic risk. 2) The CGuard™ Embolic Prevention System, which features a MicroNet™ mesh-covered stent designed to trap embolic debris. 3) The CASPER® Carotid Stent System, which also incorporates a dual-layer mesh to prevent embolization. These systems have shown promising results in recent studies and clinical trials.

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Embolic Protection System

Roadsaver Stent + Nanoparasol for Carotid Stenosis

N/A

Waitlist Available

Led By Adnan Siddiqui, MD

Research Sponsored by Microvention-Terumo, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is either symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology (amaurosis fugax ipsilateral to the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel) or asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology

Patient should have been diagnosed with carotid artery stenosis and be considered a high operative risk for carotid endarterectomy

Must not have

Patient has anticipated or potential sources of emboli (e.g. known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or deep vein thrombosis (DVT) treated within 6 months) that are not adequately treated with antithrombotics for at least two weeks with documented coagulation parameters in the target therapeutic range

Patient has an active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions to materials in the stent or protection system such as inflammation or allergic responses; complications from procedural errors like vessel damage; bleeding due to antiplatelet medication; and blockage of blood flow leading to stroke-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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

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I am between 22 and 80 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I currently have an infection.

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I have kidney failure or am on dialysis.

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I have diabetes that is not well-controlled.

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

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

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

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

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

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I have atrial fibrillation.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stent placement for Carotid Artery Stenosis involves inserting a small mesh tube into the narrowed artery to keep it open, thereby restoring normal blood flow to the brain and reducing stroke risk. The embolic protection system is used during this procedure to capture and remove debris that may dislodge and travel to the brain, preventing blockages and subsequent strokes. These treatments are crucial for patients as they address the risk of stroke by both mechanically widening the artery and preventing embolic events during the intervention.