Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Intracranial Atherosclerotic Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 80 years old;
Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70~99%(WASID method);

Exclusion criteria

Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
Ischemic cerebral infarction occurred 3 weeks before surgery;
Cerebral hemorrhage 3 months before operation;

Treatment and study plan

Drug balloon dilated

Device

Through the expansion after the balloon is in place,Release drugs on the surface of the balloon and improve the blood perfusion of nerve vessels to treat stenosis

balloon dilated

Device

Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.

Primary outcomes

6-month target lesion restenosis rate

Time frame: 6-month

Sponsors and collaborators

Lead sponsor

Bochang

Industry

Collaborators

Beijing Geriatric Hospital
First Affiliated Hospital Xi'an Jiaotong University
First People's Hospital of Hangzhou
Jinan Central Hospital
The Affiliated Hospital of Qingdao University
Xuanwu Hospital, Beijing

Registry information

Official study title

Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2026
First posted: Nov 20, 2023
Registry last updated: Nov 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting