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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
General Hospital of Northern Theater Command
Shenyang, China
RECRUITINGProportion of early neurological deterioration (NIHSS score increase of 4 points or more)
Time frame: at 24±8 hours
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
Complications associated with endovascular therapy
Time frame: at 24±8 hours, at 10±2 days, at 90±7 days
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