Balloon angioplasty for patients with minor strokes caused by narrowed brain arteries
Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study
This study is testing if a procedure called balloon angioplasty can help people who have had minor strokes from narrowed brain arteries feel better and prevent more strokes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT06763458 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of submaximal balloon angioplasty (SBA) as a treatment for patients experiencing minor ischemic strokes due to intracranial atherosclerotic stenosis (ICAS). The study focuses on patients who have not responded adequately to medical management and are at risk of early neurological deterioration. By improving blood flow through SBA, the trial aims to enhance patient outcomes and reduce the risk of further complications. Participants will be closely monitored for changes in their neurological status following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced a minor ischemic stroke within the past week and have severe stenosis due to intracranial atherosclerosis.
Not a fit: Patients with large intracranial vessel occlusion or those who have developed intracranial hemorrhagic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of early neurological deterioration in patients with minor strokes caused by ICAS.
How similar studies have performed: While the use of balloon angioplasty in stroke management is not widely tested, preliminary approaches suggest potential benefits, making this study a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 18 years of age; 2. Minor ischemic stroke within 1 week of onset (NIHSS≤5); 3. Have received the best drug treatment (dual antibody, anti-plate combined with anticoagulation), but symptoms still have measurable fluctuations or progression (NIHSS increased by at least 1 point); 4. Symptoms fluctuate to the time of receiving balloon dilation within 24 hours; 5. The etiology was considered to be severe stenosis of the responsible vessels due to intracranial arteriosclerosis (70-99% stenosis), or perforator artery disease with severe stenosis of the carrier artery (confirmed by MRA, CTA or DSA); 6. Patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points; 7. Patients or family members sign informed consent. Exclusion Criteria: 1. Patients who have developed large intracranial vessel occlusion; 2. Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.; 3. Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc. 4. Clotting disorders or systemic bleeding tendency or platelets less than 100,000; 5. Complicated with serious infection or liver, kidney and other serious diseases; 6. Patients with severe inability to control hypertension (systolic blood pressure \>200mmHg or diastolic blood pressure \>110mmHg); 7. Women who are pregnant, have a pregnancy plan or are breastfeeding; 8. Complicated with other serious diseases, life expectancy \< 6 months; Other conditions deemed inappropriate for participation in this study.
Where this trial is running
Shenyang
- General Hospital of Northern Theater Command — Shenyang, China (Recruiting)
Study contacts
- Study coordinator: Hui-Sheng Chen
- Email: chszh@aliyun.com
- Phone: +86-024-28897511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.