NCT06140550

Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Bochang · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Atherosclerotic Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2023-11-20
• Last updated: 2023-11-20