Angioplasty for Stroke Risk Reduction

Recruiting at 1 trial location

Overseen By Sepideh Amin-Hanjani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Warfarin, NOAC, Thrombolytics, others

Disqualifiers: Major stroke, Hemorrhagic infarction, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 30 days

159 Participants Needed

Trial Summary

What is the purpose of this trial?

By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility/pivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have an indication for warfarin or NOAC (blood thinners) beyond enrollment or if you have an allergy to aspirin or Plavix.

What data supports the effectiveness of the treatment Intensive medical therapy, Submaximal balloon angioplasty for stroke risk reduction?

Research shows that submaximal balloon angioplasty, a procedure to widen narrowed blood vessels in the brain, has been effective in reducing the risk of stroke in patients with severe artery narrowing. In a study, patients who underwent this treatment had a low rate of stroke recurrence and no significant complications, suggesting it may be a safe option for reducing stroke risk. ^{1 2 3 4 5}

How does submaximal balloon angioplasty differ from other treatments for stroke risk reduction?

Submaximal balloon angioplasty is unique because it involves using a smaller balloon to widen blood vessels in the brain without placing a stent, which reduces the risk of complications like vessel perforation and bleeding compared to traditional stenting methods. ^{1 2 4 6 7}

Research Team

Adnan Siddiqui, MD, PhD

Principal Investigator

University at Buffalo

Sepideh Amin-Hanjani, MD

Principal Investigator

Case Western Reserve University

Tanya Turan, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for people aged 30-90 with a recent, non-severe stroke due to 70-99% blockage in certain brain arteries. They must have specific risk factors or diseases in other blood vessels if they're under 50. Exclusions include major strokes, conditions that could affect the study's results, very short life expectancy, certain heart and blood disorders, and previous treatments on the target area.

Inclusion Criteria

I have experienced symptoms within the last 30 days.

I had a mild stroke within the last month due to a narrowed brain artery.

You have low blood flow, as determined by a specific test used in the VERiTAS Study.

Exclusion Criteria

I need blood thinners for a clot or irregular heartbeat beyond joining the study.

I do not have any brain or nerve conditions that could affect my study results.

I am allergic to or cannot take aspirin or Plavix.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo submaximal balloon angioplasty and receive intensive medical therapy

30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurological, functional, and cognitive assessments

1 year

4 visits (in-person) at 1, 4, 8, and 12 months

Interim Analysis

Interim safety analysis to determine if the intervention should continue based on periprocedural risk

Treatment Details

Interventions

• Intensive medical therapy
• Submaximal balloon angioplasty

Trial Overview The trial tests submaximal balloon angioplasty's safety and effectiveness for treating intracranial atherosclerotic stenosis (ICAS), which can lead to strokes. It aims to support future larger trials by providing initial data on this technique as an alternative when medical therapy isn't enough.

Participant Groups

Group I: Submaximal balloon angioplasty plus intensive medical therapy Experimental Treatment 1 Intervention

Endovascular intervention with submaximal balloon angioplasty

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Submaximal primary angioplasty for symptomatic intracranial atherosclerosis: peri-procedural complications and long-term outcomes. [2020]

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

Submaximal angioplasty for symptomatic intracranial atherosclerosis: a prospective Phase I study. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Atherosclerosis of carotid and vertebrobasilar arteries: prognosis and therapy decision]. [2006]

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

Intracranial Stenting: Angioplasty Basic Technique, Indications, and Sizing: 2-Dimensional Operative Video. [2022]

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

Successful percutaneous transluminal angioplasty for basilar artery stenosis: technical case report. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Submaximal angioplasty in the treatment of patients with symptomatic ICAD: a systematic review and meta-analysis. [2020]

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

Revisiting angioplasty without stenting for symptomatic intracranial atherosclerotic stenosis after the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis (SAMMPRIS) study. [2012]