The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis
Tiantan Hospital Affiliated of Peking University
Beijing, Beijing Municipality, China
Huashan Hospital Affiliated of Fudan University
Shanghai, Shanghai Municipality, China
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.
Time frame: 180±30days
Technical succeed rate
defined as smooth delivery of the device to the target lesion and successful dilatation, unloading, and retraction
Time frame: Intraoperation
Target vascular-related stroke or death at 30 days postoperatively
Time frame: 30±7days
Any stroke or death at 30 days postoperatively
Time frame: 30±7days
Target vascular-related stroke or death at 6 month postoperatively
Time frame: 180±30days
Any stroke or death at 6 month postoperatively
Time frame: 180±30days
Target vascular-related stroke or death at 12 month postoperatively
Time frame: 360±60days
Any stroke or death at 12 month postoperatively
Time frame: 360±60days
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