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NOT YET RECRUITING
NCT06140550
NA

Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

Sponsor: Bochang

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2023-11

Completion Date

2026-12

Last Updated

2023-11-20

Healthy Volunteers

No

Interventions

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

DEVICE

balloon dilated

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