Intracranial Atherosclerotic Stenosis
Conditions
Keywords
Intracranial balloon, stenosis
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 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.
Interventions
DEVICEDrug 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
DEVICEballoon dilated
Through the expansion after the balloon is in place, improve the blood perfusion of nerve vessels to treat stenosis.
Sponsors
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
Bochang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ratio of control group to test group 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month target lesion restenosis rate | 6-month |
Outcome results
None listed