Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Atherosclerotic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Ratio of control group to test group 1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Drug balloon dilated

Intervention Type 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

Control group

Group Type EXPERIMENTAL

balloon dilated

Intervention Type DEVICE

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

Interventions

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Drug balloon dilated

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

Intervention Type DEVICE

balloon dilated

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

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No