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The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental |
| |
| control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin neurovascular Balloon Catheter | Device | Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion restenosis rate at 6 month postoperative | The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method. | 180±30days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical succeed rate | defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction | Intraoperation |
| Target vascular-related stroke or death at 30 days postoperatively |
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Incsion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiantan Hospital Affiliated of Peking University | Beijing | Beijing Municipality | China | |||
| Huashan Hospital Affiliated of Fudan University |
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| Conventional Balloon | Device | Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis |
|
| 30±7days |
| Any stroke or death at 30 days postoperatively | 30±7days |
| Target vascular-related stroke or death at 6 month postoperatively | 180±30days |
| Any stroke or death at 6 month postoperatively | 180±30days |
| Target vascular-related stroke or death at 12 month postoperatively | 360±60days |
| Any stroke or death at 12 month postoperatively | 360±60days |
| Shanghai |
| Shanghai Municipality |
| China |