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NOT YET 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

2026-04-21

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.