Angioplasty for Stroke Risk Reduction

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals at high risk of stroke due to severe blockages in the brain's blood vessels, known as intracranial atherosclerotic stenosis (ICAS). The treatment involves submaximal balloon angioplasty, a procedure that uses a small balloon to widen narrowed brain blood vessels. Individuals who have experienced a recent mild stroke and have severe narrowing in specific brain arteries might be suitable candidates. The trial aims to determine the safety and effectiveness of this procedure, potentially leading to improved stroke prevention options worldwide. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could significantly enhance global stroke prevention strategies.

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 prior data suggests that this endovascular intervention is safe for treating intracranial atherosclerotic stenosis?

Research has shown that submaximal balloon angioplasty is generally well-tolerated by patients. One study found that the chances of having a stroke or dying within 30 days after the procedure were relatively low, at 3.2% and 1.6%, respectively. Reviews of multiple studies suggest that this type of angioplasty has fewer complications compared to other treatments like stenting.

Another study demonstrated that submaximal balloon angioplasty, which involves inflating a balloon to about 50-80% of the normal size of the blood vessel, results in a low rate of complications and good outcomes for patients. Additionally, this procedure does not significantly increase the risk of stroke or death within the first 30 days, making it a safer option for treating the narrowing of brain arteries that can lead to strokes.

Overall, these findings indicate that submaximal balloon angioplasty is a safe treatment choice with a good safety profile for patients at high risk of stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard stroke prevention methods, which often include medications like antiplatelets or anticoagulants, submaximal balloon angioplasty offers a unique approach by physically opening up narrowed blood vessels in the brain. This technique involves gently inflating a small balloon inside the artery to improve blood flow, which can directly reduce the risk of stroke. Researchers are excited about this method because it targets the problem at its source, potentially offering faster and more effective stroke risk reduction compared to medication alone. Additionally, it may provide an option for patients who cannot tolerate long-term medication use.

What evidence suggests that submaximal balloon angioplasty could be an effective treatment for intracranial atherosclerotic stenosis?

Research has shown that submaximal balloon angioplasty, administered alongside intensive medical therapy, might be promising for treating intracranial atherosclerotic stenosis (ICAS), a condition involving the narrowing of brain arteries. Studies have found this treatment effective, potentially balancing early safety with long-term benefits. Submaximal balloon angioplasty involves partially inflating a small balloon in the narrowed artery to improve blood flow. This method has been linked to good results and a low risk of complications, suggesting it could be a valuable option for patients at high risk of stroke due to ICAS. ^{1 3 5 6 7}

Who Is on the Research Team?

Adnan Siddiqui, MD, PhD

Principal Investigator

University at Buffalo

Tanya Turan, MD

Principal Investigator

Medical University of South Carolina

Sepideh Amin-Hanjani, MD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39235816/

Balloon Angioplasty vs Medical Management for ... In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2823274

Balloon Angioplasty vs Medical Management for ... The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS.

3. ahajournals.org ahajournals.org/doi/abs/10.1161/STROKEAHA.124.049467

Submaximal Angioplasty for Severe Intracranial ... Submaximal balloon angioplasty might be in the sweet spot between mitigating early complications and securing long-term efficacy.

4. jnis.bmj.com jnis.bmj.com/content/early/2025/01/24/jnis-2024-022738

Submaximal versus aggressive angioplasty with drug ... Submaximal balloon angioplasty (50–80% of the normal vessel diameter) shows a low rate of perioperative complications and good clinical outcomes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162115/

Balloon angiopLasty for intracranial Atherosclerotic minor ... The BLAST study will provide evidence regarding whether early SBA can reduce stroke recurrence and mortality in patients with minor stroke/TIA ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11378071/

Balloon Angioplasty vs Medical Management for Intracranial ... Meta-analyses suggest that submaximal balloon angioplasty may have lower rates of periprocedural complications than stenting and a high ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1513086/full

Safety assessment of symptomatic intracranial ... In conclusion, this study indicates that balloon angioplasty does not significantly increase the 30-day risk of stroke or death in patients with ...