Balloon angioplasty for patients with minor strokes caused by narrowed brain arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• General Hospital of Northern Theater Command
  Shenyang, China Recruiting

Study contacts

• Study coordinator: Hui-Sheng Chen
• Email: chszh@aliyun.com
• Phone: +86-024-28897511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.