Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBochang
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Drug balloon dilated
- balloon dilated
Treatment groups
204 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Bochang
Lead sponsor
Xuanwu Hospital, Beijing
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
First People's Hospital of Hangzhou
Collaborator
Jinan Central Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Beijing Geriatric Hospital
Collaborator
Source ClinicalTrials.gov