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Angioplasty

Angioplasty for Stroke Risk Reduction

N/A
Waitlist Available
Led By Sepideh Amin-Hanjani, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial
Hemodynamic compromise based on borderzone infarct pattern* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA** for the posterior circulation (vertebral and basilar artery stenosis)
Must not have
Indication for warfarin or NOAC beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation)
Any neurological disease which would confound follow-up assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a minimally-invasive endovascular intervention can be performed safely in patients with a high risk of stroke due to atherosclerosis, as well as its effect on stroke risk.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, potential side effects may include risks associated with angioplasty such as bleeding at the catheter insertion site, damage to blood vessels from the balloon or catheter, infection risk from invasive procedures and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a mild stroke within the last month due to a narrowed brain artery.
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I have poor blood flow in my brain due to narrowed arteries.
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I am between 30 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need blood thinners for a clot or irregular heartbeat beyond joining the study.
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I do not have any brain or nerve conditions that could affect my study results.
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I am allergic to or cannot take aspirin or Plavix.
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I have a heart condition that increases my risk of blood clots.
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I have a blood disorder such as polycythemia vera, essential thrombocytosis, or sickle cell disease.
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I do not have a health condition that limits my life expectancy to less than 12 months.
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I have had a severe stroke that significantly affects my daily activities.
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I don't have active bleeding, recent major bleeding, severe stomach ulcers, very low platelets, or severe liver problems.
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My blood vessel narrowing is complex and previously treated with a device.
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I had a large stroke that could lead to bleeding in the brain.
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I cannot or do not want to have an MRI scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedural Safety
Secondary study objectives
Clinical Efficacy
Hemodynamic Durability
Hemodynamic Success

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: Submaximal balloon angioplasty plus intensive medical therapyExperimental Treatment1 Intervention
Endovascular intervention with submaximal balloon angioplasty

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,627 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
309 Previous Clinical Trials
251,100 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
652,091 Total Patients Enrolled
Sepideh Amin-Hanjani, MDPrincipal InvestigatorCase Western Reserve University
2 Previous Clinical Trials
382 Total Patients Enrolled
Adnan Siddiqui, MDPrincipal InvestigatorUniversity at Buffalo
1 Previous Clinical Trials
295 Total Patients Enrolled
Tanya Turan, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Submaximal balloon angioplasty (Angioplasty) Clinical Trial Eligibility Overview. Trial Name: NCT03729817 — N/A
Intracranial Atherosclerosis Research Study Groups: Submaximal balloon angioplasty plus intensive medical therapy
Intracranial Atherosclerosis Clinical Trial 2023: Submaximal balloon angioplasty Highlights & Side Effects. Trial Name: NCT03729817 — N/A
Submaximal balloon angioplasty (Angioplasty) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03729817 — N/A
~106 spots leftby Oct 2029
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