Balloon angioplasty for minor strokes and TIAs caused by intracranial atherosclerosis

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study

This study is testing if adding balloon angioplasty to standard medical treatment can help people who have had minor strokes or TIAs caused by narrowed brain arteries feel better and have fewer problems.

Quick facts

• Study type: Observational
• Enrollment: 416 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06014723 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy compared to medical therapy alone in patients who have experienced minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis. A total of 416 patients from 20 centers in China will be enrolled and followed for one year to assess outcomes. The intervention group will receive balloon angioplasty, while the control group will receive standard medical therapy. The study aims to determine if the addition of angioplasty improves patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30-80 with minor strokes or TIAs due to symptomatic intracranial atherosclerosis.

Not a fit: Patients with non-atherosclerotic stenosis or significant ischemic regions on imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients with intracranial atherosclerosis.

How similar studies have performed: Other studies have shown promising results with similar angioplasty approaches in different vascular territories, suggesting potential for success in this context.

Eligibility criteria

Inclusion Criteria:

1. age range of 30-80 years;
2. symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;
3. minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;
4. diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
5. mRS ≤ 2 before endovascular treatment；
6. no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；
7. written informed consent obtained from the patient or legally responsible person.

Exclusion Criteria:

1. allergy to contrast media;
2. non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
3. penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction);
4. presence of severe stenosis of the extracranial segment on the side of the target lesion;
5. previous endovascular treatment of the ipsilateral vessel;
6. presence of intracranial aneurysms, tumors, and vascular malformations;
7. any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
8. presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
9. hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR\> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
10. uncontrollable hypertension: systolic blood pressure \>185 mmHg and/or diastolic blood pressure \>110 mmHg;
11. poor glycemic control (random blood glucose \> 22.2 mmol/L);
12. history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
13. pregnancy or lactation;
14. other conditions that the researchers think make the patient unsuitable for the study.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Shouchun Wang, MD, PhD

Conditions Ischemic Stroke