This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
The neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon.
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Cangzhou Central hospital
Cangzhou, Hebei, China
Restenosis rate of the target lesion
Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens.
Time frame: 180+60 days
Average stenosis degree of the target lesion
Subjects receive DSA / CTA examination in 180 days.
Time frame: 180+60 days
Success rate of device
After receiving DSA examination, success rate of device is defined as experimental device-neurovascular drug-eluting balloon dilatation catheter advanced on position successfully, balloon retracted smoothly after expanded, without balloon rupture and balloon catheter break, etc.
Time frame: Intraoperation
Success rate of surgery
After receiving DSA examination, success rate of surgery is defined as the final residual stenosis degree of target lesion\<50% and modified thrombolysis in cerebral infarction score (mTICI) 2b/3, whether or not other additional treatments are applied.
Time frame: Intraoperation
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Wuhan Hospital of Traditional Chinese and Western Medicine
Wuhan, Hubei, China
General Hospital of Northen Theater Command
Shenyang, Liaoning, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
...and 1 more locations