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Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
Sponsor: Bochang
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
Conditions
Interventions
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
balloon dilated
Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.