Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke, especially in East and South Asia, and is significantly associated with stroke recurrence and early neurological deterioration (END) despite aggressive medical management. Minor stroke (National Institutes of Health Stroke, NIHSS score ≤ 5) patients with ICAS often has higher risk of END. The early realization of blood flow patency is closely related to the improvement of patient outcomes. Submaximal balloon angioplasty (SBA) as a safer and simpler intervention which can improve cerebral blood flow. Thus, SBA may be an effective strategy for preventing END in acute ischemic stroke patients with ICAS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Over 18 years of age;

• Minor ischemic stroke within 1 week of onset (NIHSS≤5);

• 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);

• Symptoms fluctuate to the time of receiving balloon dilation within 24 hours;

• 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);

• 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;

• Patients or family members sign informed consent.

Locations
Other Locations
China
General Hospital of Northern Theater Command
RECRUITING
Shenyang
Contact Information
Primary
Hui-Sheng Chen
chszh@aliyun.com
+86-024-28897511
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 100
Treatments
Experimental: SBA group
Receiving SBA plus best medical therapy
No_intervention: Control group
Receiving best medical therapy
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region

This content was sourced from clinicaltrials.gov