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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBA group | Experimental | Receiving SBA plus best medical therapy |
|
| Control group | No Intervention | Receiving best medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Submaximal balloon angioplasty | Procedure | The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of early neurological deterioration (NIHSS score increase of 4 points or more) | at 24±8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The decrease of NIHSS score | at 24±8 hours | |
| The decrease of NIHSS score | at 10±2 days | |
| Proportion of early neurological improvement (NIHSS score decline of 4 points or 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cortical oxygen saturation | at 24±8 hours | |
| Changes of cerebral blood flow autoregulation function | at 24±8 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Sheng Chen | Contact | +86-024-28897511 | chszh@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Recruiting | Shenyang | 110840 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| at 24±8 hours |
| Proportion of patients with modified Rankin Score 0 to 1 | at 90±7 days |
| Proportion of patients with modified Rankin Score 0 to 2 | at 90±7 days |
| Distribution of patients with modified Rankin Score | at 90±7 days |
| the occurence of stroke or other cardiovascular events | at 90±7 days |
| ischemic stroke in the culprit artery territory | at 90±7 days |
| Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria) | at 24±8 hours |
| Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2) | at 24±8 hours |
| Proportion of serious adverse events | at 24±8 hours |
| Proportion of all-cause deaths | at 10±2 days |
| Complications associated with endovascular therapy | at 24±8 hours, at 10±2 days, at 90±7 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |