Status:
NOT_YET_RECRUITING
Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
Lead Sponsor:
Bochang
Collaborating Sponsors:
Xuanwu Hospital, Beijing
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Intracranial Atherosclerotic Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06140550
Start Date
November 1 2023
End Date
December 1 2026
Last Update
November 20 2023
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