Roadsaver Stent + Nanoparasol for Carotid Stenosis

Recruiting at 36 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Microvention-Terumo, Inc.

Must not be taking: Antithrombotics, Antiplatelets, Heparin

Disqualifiers: Stroke, Atrial fibrillation, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

295 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a sensitivity to standard medications like antiplatelet therapy, you may not be eligible to participate.

What data supports the effectiveness of the Roadsaver Stent + Nanoparasol treatment for carotid stenosis?

Research shows that the Roadsaver stent, which is a double-layer micromesh stent, is designed to improve plaque coverage and reduce the risk of small particles breaking off and causing a stroke. Studies have reported its effectiveness in reducing the risk of stroke in patients with carotid artery disease by providing better plaque coverage compared to other stents. ^{1 2 3 4 5}

Is the Roadsaver Stent + Nanoparasol safe for humans?

The Roadsaver stent has been studied for its safety in treating carotid artery disease, showing it can reduce the risk of stroke by improving plaque coverage in the arteries. While it is associated with some risk of stroke during and shortly after the procedure, it is designed to minimize these risks compared to other treatments. ^{1 2 3 4 5}

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.

Research Team

Adnan Siddiqui, MD

Principal Investigator

University of Buffalo - Neurosurgery

Chris Metzger, MD

Principal Investigator

Wellmont CVA Heart Institute

Peter Schneider, MD

Principal Investigator

Kaiser Permanente Moanalua Medical Center

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

Patient or authorized legal representative is willing to provide written informed consent prior to enrollment in study

I can follow the study rules and be reached by phone.

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

Exclusion Criteria

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

You are allergic to heparin or have had a serious reaction to it in the past.

I currently have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure

Participants undergo pre-procedure evaluations to prepare for the index procedure

1 week

Index procedure

Participants receive the Roadsaver Carotid Stent System and Nanoparasol embolic protection system

1 day

Post-procedure

Participants are monitored immediately after the procedure for any adverse events

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Visits at 30 days, 6 months, 12 months, 24 months, and 36 months

Treatment Details

Interventions

• Nanoparasol® Embolic Protection System
• Roadsaver™ Carotid Artery Stent Device

Trial Overview 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.

Participant Groups

Group I: Single-arm, open label Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Microvention-Terumo, Inc.

Lead Sponsor

Trials

32

Recruited

7,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. [2020]

2. France pubmed.ncbi.nlm.nih.gov

Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the micromesh Roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

"Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)". [2022]

5. France pubmed.ncbi.nlm.nih.gov

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery. [2017]