intracranial aneurysm
Conditions
Interventions
Test group:Intracranial stent system
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 = 4mm or tumor body / neck ratio = 2.0mm and <= 4.5mm; 4. subjects or their legal guardians agreed to participate in this trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Imaging confirmed that the target aneurysms were fusiform aneurysms, dissecting aneurysms, vesicular aneurysms, pseudoaneurysms, infective aneurysms or arteriovenous malformations and moyamoya-related aneurysms; 2. evaluated by the researchers, there were multiple aneurysms requiring treatment within 1 year after operation (except for multiple aneurysms that could be completely covered by the same stent); 3. aneurysm neck > 22mm; 4. the target aneurysm and its parent artery have received other treatment in the past, which may affect the stent implantation and evaluation of the effect; 5. preoperative modified Rankin score (mRS) >= 3; 6. patients with ruptured intracranial aneurysm or ruptured aneurysm with Hunt&Hess grade >= III within 30 days; 7. received cardio-cerebrovascular surgery or interventional therapy within 30 days; 8. severe dissection of vascular pathway or parent artery, or severe cerebral vasospasm, or stenosis of more than 50% due to atherosclerosis, making it difficult for test instruments to reach the lesion site or requiring simultaneous surgical treatment; 9. complicated with severe hepatic and renal insufficiency (glutamic pyruvic transaminase (ALT) or aspartate oxaloacetic transaminase (AST) > 3 times the upper limit of normal value. Serum creatinine > 3.0mg/dL (266umol/L) or dialysis); 10. patients with active infection; 11. patients with intracranial tumors or undergoing radiotherapy and chemotherapy; 12. those who are contraindicated by angiography or antiplatelet and / or anticoagulation therapy (such as aspirin, clopidogrel, heparin, etc.) or complicated with coagulation disorders; 13. patients with platelet 3.5; 14. previously identified allergic patients with nickel-titanium or platinum-iridium alloy materials; 15. patients with an expected survival time of less than 1 year; 16. pregnant or lactating women, or those who have planned pregnancy during this trial; 17. those who are participating in clinical trials of any other drugs or medical devices and are not yet out of the group; 18. those who are considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate 360 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate. ;Complete occlusion rate of target aneurysm. ;Target aneurysm retreatment rate.;Incidence of parent artery stenosis.;Improved Rankin score. ;Evaluation of the performance of intraoperative instruments.; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Xuanwu Hospital of Capital Medical University
Outcome results
None listed