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Recruiting NCT06763458

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

No phase Interventional Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Submaximal balloon angioplasty.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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%.

Primary outcome measures

  • Proportion of early neurological deterioration (NIHSS score increase of 4 points or more) [Time frame: at 24±8 hours]
Secondary outcome measures (12)
  • The decrease of NIHSS score [Time frame: at 24±8 hours]
  • The decrease of NIHSS score [Time frame: at 10±2 days]
  • Proportion of early neurological improvement (NIHSS score decline of 4 points or 0) [Time frame: at 24±8 hours]
  • Proportion of patients with modified Rankin Score 0 to 1 [Time frame: at 90±7 days]
  • Proportion of patients with modified Rankin Score 0 to 2 [Time frame: at 90±7 days]
  • Distribution of patients with modified Rankin Score [Time frame: at 90±7 days]
  • the occurence of stroke or other cardiovascular events [Time frame: at 90±7 days]
  • ischemic stroke in the culprit artery territory [Time frame: at 90±7 days]
  • Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria) [Time frame: at 24±8 hours]
  • Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2) [Time frame: at 24±8 hours]
  • Proportion of serious adverse events [Time frame: at 24±8 hours]
  • Proportion of all-cause deaths [Time frame: at 10±2 days]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT06763458 · Y(2024)262

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗