Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)

NCT06763458 | Recruiting DMC

• 1 other identifier: Y(2024)262
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

stroke; Submaximal balloon angioplasty; early neurological deterioration; Intracranial atherosclerotic stenosis

Outcome Measures

Primary Outcomes (1)

• Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)

  at 24±8 hours

Secondary Outcomes (13)

• The decrease of NIHSS score

  at 24±8 hours

• The decrease of NIHSS score

  at 10±2 days

• Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)

  at 24±8 hours

• Proportion of patients with modified Rankin Score 0 to 1

  at 90±7 days

• Proportion of patients with modified Rankin Score 0 to 2

  at 90±7 days

Other Outcomes (2)

• Changes in cortical oxygen saturation

  at 24±8 hours

• Changes of cerebral blood flow autoregulation function

  at 24±8 hours

Study Arms (2)

SBA group

EXPERIMENTAL

Receiving SBA plus best medical therapy

Procedure: Submaximal balloon angioplasty

Control group

NO INTERVENTION

Receiving best medical therapy

Interventions

Submaximal balloon angioplasty PROCEDURE

The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.

SBA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have developed large intracranial vessel occlusion;
• Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
• Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc.
• Clotting disorders or systemic bleeding tendency or platelets less than 100,000;
• Complicated with serious infection or liver, kidney and other serious diseases;
• Patients with severe inability to control hypertension (systolic blood pressure \>200mmHg or diastolic blood pressure \>110mmHg);
• Women who are pregnant, have a pregnancy plan or are breastfeeding;
• Complicated with other serious diseases, life expectancy \< 6 months; Other conditions deemed inappropriate for participation in this study.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hui-Sheng Chen

CONTACT

+86-024-28897511; chszh@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 8, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)