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A multicenter, randomized, open-label, endpoint-blinded trial to compare the effects of endovascular recanalization plus aggressive medical management with aggressive medical management alone on stroke recurrence and mortality in patients with symptomatic non-acute intracranial artery occlusion.
This is a multicenter, randomized, open-label, endpoint-blinded trial comparing endovascular recanalization (ER) plus aggressive medical management (AMM) with aggressive medical management alone in patients with symptomatic non-acute intracranial artery occlusion. Randomization will be performed using a central interactive web response system (IWRS) with a 1:1 minimization method, stratified by age (<65 years vs ≥65 years), time from the last ischemic event to randomization (14-30 days vs 30-90 days), and occlusion site (anterior circulation vs posterior circulation). The primary endpoint is a composite of any stroke or death within 30 days after randomization or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Endovascular Recanalization Group |
|
| Control group | Other | Aggressive Medical Management Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Recanalization Strategy | Procedure | Balloon angioplasty and/or stenting;Combined with aggressive medical management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization | Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization. | Within 1 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality within 1 year after randomization | All cause mortality within 1 year after randomization. | Within 1 year after randomization |
| Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization |
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Clinical inclusion criteria:
Imaging inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Gao, MD | Contact | 13581936066 | gaofengletter@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Gao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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| Aggressive Medical Management | Drug | 100 mg aspirin per day throughout the follow-up period and 75 mg clopidogrel per day (or ticagrelor or cilostazol) for the initial 90 days after randomization;Cerebrovascular risk factor management. |
|
Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization.
| Within 1 year after randomization |
| Disabling stroke within 1 year after randomization, defined as any of the following | Disabling stroke within 1 year after randomization, defined as any of the following: ① modified Rankin Scale (mRS) score ≥3; ② an increase of ≥1 in the mRS score from baseline after stroke; ③ National Institutes of Health Stroke Scale (NIHSS) total score ≥7; ④ an increase of ≥4 in the NIHSS score from baseline after stroke. | Within 1 year after randomization |
| TIA in the same region as the qualifying artery within 1 year after randomization | TIA in the same region as the qualifying artery within 1 year after randomization. | Within 1 year after randomization |
| Unplanned revascularization (extracranial intracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization | Unplanned revascularization (extracranialintracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization. | Within 1 year after randomization |
| Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction | Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction. | Within 1 year after randomization |
| A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization | A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization. | Within 1 year after randomization |
| mRS score at 1 year after randomization | mRS score at 1 year after randomization. | Within 1 year after randomization |
| Re occlusion rate at 1 year after randomization | Re occlusion rate at 1 year after randomization. | Within 1 year after randomization |
| Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications | Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications: in-stent thrombosis; distal embolism; symptomatic intracranial hemorrhage; parenchymal hematoma type 2 (as defined by the Heidelberg classification); arterial dissection; and vessel perforation. | At the end of the operation or intraoperative |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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