Clinical trial NCT06763458: Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)
Official title: Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: stroke
Submaximal balloon angioplasty
early neurological deterioration
Intracranial atherosclerotic stenosis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
timeFrame: at 24±8 hours
Secondary outcomes:
measure: The decrease of NIHSS score
timeFrame: at 24±8 hours
measure: The decrease of NIHSS score
timeFrame: at 10±2 days
measure: Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)
timeFrame: at 24±8 hours
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: at 90±7 days
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: at 90±7 days
measure: Distribution of patients with modified Rankin Score
timeFrame: at 90±7 days
measure: the occurence of stroke or other cardiovascular events
timeFrame: at 90±7 days
measure: ischemic stroke in the culprit artery territory
timeFrame: at 90±7 days
measure: Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)
timeFrame: at 24±8 hours
measure: Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)
timeFrame: at 24±8 hours
measure: Proportion of serious adverse events
timeFrame: at 24±8 hours
measure: Proportion of all-cause deaths
timeFrame: at 10±2 days
measure: Complications associated with endovascular therapy
timeFrame: at 24±8 hours, at 10±2 days, at 90±7 days
Other outcomes:
measure: Changes in cortical oxygen saturation
timeFrame: at 24±8 hours
measure: Changes of cerebral blood flow autoregulation function
timeFrame: at 24±8 hours
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: