Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06763458

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

Led by General Hospital of Shenyang Military Region · Updated on 2026-04-27

100

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Minor ischemic stroke within 1 week of onset with NIHSS score of 5 or less
  • Received best drug treatment (dual antiplatelet plus anticoagulation) but symptoms still fluctuate or progress (NIHSS increase by at least 1 point)
  • Symptoms fluctuate up to the time of receiving balloon dilation within 24 hours
  • Severe narrowing (70-99%) of responsible intracranial vessels or perforator artery disease confirmed by imaging (MRA, CTA, or DSA)
  • First stroke or past stroke without disabling sequelae affecting NIHSS score; mRS score less than 2 if past onset
  • Patient or family provides signed informed consent
Not Eligible

You will not qualify if you...

  • Large intracranial vessel occlusion
  • Intracranial hemorrhagic diseases in past 3 months (e.g., cerebral hemorrhage, subarachnoid hemorrhage)
  • Non-atherosclerotic stenosis causes (arterial dissection, moya-moya disease, arterioinflammatory disease)
  • Clotting disorders, systemic bleeding tendencies, or platelets below 100,000
  • Serious infections or severe liver, kidney, or other diseases
  • Severe uncontrolled hypertension (systolic >200 mmHg or diastolic >110 mmHg)
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Other serious diseases with life expectancy less than 6 months or conditions deemed unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

General Hospital of Northern Theater Command

Shenyang, China, 110840

Actively Recruiting

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Research Team

H

Hui-Sheng Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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