Roadsaver Stent + Nanoparasol for Carotid Stenosis

Not currently recruiting at 37 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two medical devices, the Roadsaver™ Carotid Stent System and the Nanoparasol® Embolic Protection System, to treat carotid artery stenosis, a condition where the arteries supplying blood to the brain narrow. The researchers aim to determine if these devices can safely and effectively assist individuals at high risk for complications from traditional surgery. Individuals diagnosed with carotid artery stenosis and considered high-risk for surgery might be suitable candidates, particularly if they have experienced issues with previous neck surgeries or have heart-related conditions. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those seeking alternatives to traditional surgery.

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 prior data suggests that the Roadsaver™ Carotid Artery Stent Device and Nanoparasol® Embolic Protection System are safe for treating carotid artery stenosis?

Research has shown that the Roadsaver Carotid Stent Device and the Nanoparasol Embolic Protection System are generally safe for people. Studies indicate that the Roadsaver stent is well-tolerated, with few serious side effects. For instance, in a study with 100 patients, the Roadsaver stent demonstrated good results, with a low rate of complications both shortly after the procedure and four months later.

Similarly, testing has confirmed the safety of using the Roadsaver stent together with the Nanoparasol system. Results from both immediate and one-year follow-ups show that these devices work well together with minimal risk.

Overall, these treatments have been used in various situations and have proven to be safe with few side effects. This provides confidence in their use for patients needing treatment for carotid artery stenosis, which is the narrowing of the arteries in the neck. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Roadsaver™ Carotid Artery Stent Device combined with the Nanoparasol® Embolic Protection System because it offers a unique approach to treating carotid artery stenosis. Unlike traditional treatments like carotid endarterectomy or standard carotid stenting, this combination aims to reduce the risk of stroke by using an advanced stent system alongside a novel embolic protection method. The Nanoparasol® system specifically helps capture and remove debris during the procedure, potentially minimizing complications and improving patient outcomes. This innovative strategy could provide a safer alternative for patients at high risk for adverse events from standard surgical interventions.

What evidence suggests that the Roadsaver Stent and Nanoparasol are effective for carotid stenosis?

Research shows that the Roadsaver Carotid Stent System, used with the Nanoparasol Embolic Protection System, effectively treats carotid artery stenosis, the narrowing of the carotid artery. Studies have demonstrated that this combination can significantly reduce artery narrowing from about 85% to 11%. Both during the procedure and one year after, outcomes have proven safe and effective. The Roadsaver stent catches debris during the procedure, lowering the risk of stroke. This helps maintain smooth blood flow and reduces complications for patients at risk.

In this trial, participants will receive the Roadsaver Carotid Stent System along with the Nanoparasol Embolic Protection System to evaluate its safety and effectiveness for treating carotid artery stenosis in patients at elevated risk for adverse events following carotid endarterectomy. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210030B.pdf

summary of safety and effectiveness data (ssed) Both periprocedural and one-year outcomes have established the safety and effectiveness of the Roadsaver Carotid Stent System used in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02657707

Evaluation of the Roadsaver Stent Used in Conjunction ... To evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection ...

3. terumo.com terumo.com/newsrelease/detail/20250527/6606

Terumo Interventional Systems Announces Commercial ... Indicated for use with the Nanoparasol® Embolic Protection System, ROADSAVER Stent System addresses carotid artery stenosis in patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528512/

One-size-fits-all strategy in carotid artery treatment using ... This pilot study assesses the feasibility and clinical outcomes of the 10-mm CGuard stent in a one-size-fits-all sizes protocol. Materials and ...

5. terumoneuro.com terumoneuro.com/clinical-education/ischemic-stroke

Ischemic Stroke The objective of Cohort II is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11958397/

30-Day Outcomes of Real-World Elective Carotid Stenosis ... Dual-layer micromesh carotid artery stenting is safe, with a low 30-day major adverse event incidence in real-world asymptomatic and symptomatic ...