To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
The Medeliver® intracranial drug-coated balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment while simultaneously delivering an anti-proliferative agent (sirolimus/rapamycin) coated on the balloon surface to the lesion site.
The Diveroad® intracranial balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment.
首都医科大学宣武医院
Beijing, Beijing Municipality, China
RECRUITING福建医科大学附属协和医院
Fuzhou, Fujian, China
The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel.
Time frame: From enrollment to the end of follow-up at 12 months
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河北省人民医院
Shijiazhuang, Hebei, China
RECRUITING哈尔滨医科大学附属第一医院
Harbin, Heilongjiang, China
RECRUITING南阳市中心医院
Nanyang, Henan, China
RECRUITING河南省人民医院(包含总院及北院区)
Zhengzhou, Henan, China
RECRUITING郑州大学第一附属医院(包含河医院区、郑东院区、南院区)
Zhengzhou, Henan, China
RECRUITING包头市中心医院
Baotou, Inner Mongolia, China
RECRUITING西安交通大学第一附属医院(包含总院及港务院区)
Xi'an, Shaanxi, China
RECRUITING山东大学齐鲁医院
Ji'nan, Shandong, China
RECRUITING...and 5 more locations