Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

Not Applicable

Not yet recruiting

• Conditions: Intracranial Atherosclerotic Stenosis
• Interventions: Device: Drug balloon dilated; Device: balloon dilated

• Registration Number: NCT06140550
• Lead Sponsor: Bochang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Study First Posted: 2023-11-20
• Last Update Posted: 2023-11-20
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Drug balloon dilated	-
Control group	balloon dilated	-

Primary Outcome Measures

Name	Time	Method
6-month target lesion restenosis rate	6-month