Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

• Sponsor: Bochang (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06140550
• Collaborator: Xuanwu Hospital, Beijing (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), First People's Hospital of Hangzhou (Other), Jinan Central Hospital (Other), The Affiliated Hospital of Qingdao University (Other), Beijing Geriatric Hospital (Other)
• Enrollment: 204
• Arms: 2
• Anticipated Duration (Months): 37

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Atherosclerotic Stenosis	Device: Drug balloon dilated; Device: balloon dilated	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Ratio of control group to test group 1:1Ratio of control group to test group 1:1
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	Device: 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
Experimental: Control group	Device: balloon dilated; Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.

Outcome Measures

Primary Outcome Measures

1. 6-month target lesion restenosis rate [6-month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bochang
• ClinicalTrials.gov Identifier: NCT06140550
• Other Study ID Numbers: TP-NS-036
• First Posted: Nov 20, 2023
• Last Update Posted: Nov 20, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bochang: Intracranial balloon; stenosis
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Nov 20, 2023