About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Submaximal balloon angioplasty
Procedure/SurgeryThe goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
Secondary outcomes
The decrease of NIHSS score
The decrease of NIHSS score
Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)
Proportion of patients with modified Rankin Score 0 to 1
Other outcomes
Changes in cortical oxygen saturation
Changes of cerebral blood flow autoregulation function
Sponsors and contacts
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