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RECRUITING
NCT07542938
NA

Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

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.

Official title: Safety and Efficacy of Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis(Prospective, Multicenter, Randomized Controlled, Superiority Trial)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2026-04-15

Completion Date

2027-11-30

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DEVICE

Intracranial Drug-Coated Balloon Catheter (Medeliver®)

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.

DEVICE

Intracranial Balloon Dilatation Catheter (Diveroad®)

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.

Locations (15)

首都医科大学宣武医院

Beijing, Beijing Municipality, China

福建医科大学附属协和医院

Fuzhou, Fujian, China

河北省人民医院

Shijiazhuang, Hebei, China

哈尔滨医科大学附属第一医院

Harbin, Heilongjiang, China

南阳市中心医院

Nanyang, Henan, China

河南省人民医院(包含总院及北院区)

Zhengzhou, Henan, China

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

包头市中心医院

Baotou, Inner Mongolia, China

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

山东大学齐鲁医院

Ji'nan, Shandong, China

济南市中心医院

Ji'nan, Shandong, China

山东省立医院(包含老院区及东院区)

Ji'nan, Shandong, China

青岛大学附属医院

Qingdao, Shandong, China

复旦大学附属华山医院(包含总院及西院区)

Shanghai, Shanghai Municipality, China

上海交通大学医学院附属仁济医院

Shanghai, Shanghai Municipality, China