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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Submaximal balloon angioplasty

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui-Sheng Chen; Phone Number: +86-024-28897511; Email: chszh@aliyun.com

Study Locations

• China
  • Shenyang, China, 110840
    • Recruiting
    • General Hospital of Northern Theater Command
    • Contact: Zi-Ai Zhao; Phone Number: +862428897491; Email: zhaoziai@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBA group; Receiving SBA plus best medical therapy	Procedure: Submaximal balloon angioplasty; The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
No Intervention: Control group; Receiving best medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)	at 24±8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Distribution of patients with modified Rankin Score	at 90±7 days
the occurence of stroke or other cardiovascular events	at 90±7 days
ischemic stroke in the culprit artery territory	at 90±7 days
Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)	at 24±8 hours
Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)	at 24±8 hours
Proportion of serious adverse events	at 24±8 hours
Proportion of all-cause deaths	at 10±2 days
Complications associated with endovascular therapy	at 24±8 hours, at 10±2 days, at 90±7 days

Other Outcome Measures

Outcome Measure	Time Frame
Changes in cortical oxygen saturation	at 24±8 hours
Changes of cerebral blood flow autoregulation function	at 24±8 hours

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stroke; Intracranial atherosclerotic stenosis; Submaximal balloon angioplasty; early neurological deterioration
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: Y(2024)262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No