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Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter

StatusNot Yet Recruiting
PhaseNot applicable
SponsorBochang
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 20, 2023 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
Bochang
1 trial monitored
See all monitored trials
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.
Trial Details
NCT Number NCT06140550
Lead Sponsor Bochang
Collaborators: 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
Conditions
(from sponsor)		 Intracranial Atherosclerotic Stenosis
Related terms Constriction, Pathologic
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov