Wde-neck bifurcation aneurysm
Conditions
Interventions
Experimental group:Self-expanding aneurysmal disturbance device
Sponsors
Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 (inclusive); 2. Target aneurysm must have the following characteristics at the same time: a) at the bifurcation of an artery in the anterior or posterior circulation; b) The aneurysm was saccular, and the equatorial diameter/neck diameter of the aneurysm was >=1; c) aneurysmal neck diameter =4mm. 3. If the aneurysm ruptures, the subject should have stable nervous system function, and the Hunt-Hess rating should be grade I-II; 4. Voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.The presence of endovascular or surgical conditions other than target aneurysms such as vascular spasm, vasculitis, intracranial tumours (except meningiomas) and cerebrovascular malformations; 2.The target aneurysm contains an implant (e.g., spring coil); 3. >50% stenosis of the aneurysm-carrying artery; 4. Patients with severe coagulation disorders or uncontrolled bleeding disorders as judged by the investigator; 5. The presence of contraindications to anticoagulation or antiplatelet therapy; 6. Significant hepatic or renal insufficiency (creatinine >2.50 mg/dl or 221 µmol/L, AST or ALT >3 times ULN); andALT > 3 times ULN); 7. Imaging that shows tortuous vascular paths, difficulty in reaching the target position of the test device or difficulty in retrieving the test device.(e.g., the test device is difficult to reach the target position or difficult to retrieve); 8. Myocardial infarction or stroke within the last 3 months; 9. A known allergy to Nitinol or contrast media; 10.Pregnant, breastfeeding, or planning to become pregnant within one year; 11. The subject has a life expectancy of less than 1 year due to other diseases or conditions; and 12. In the opinion of the investigator, endovascular treatment is not appropriate; 13. Subjects who are enrolled in a clinical trial of another medical device or drug during the same period of time; 14. Other conditions that, in the judgement of the investigator, make enrolment in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm complete occlusion rate 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Release success rate;Aneurysmal occlusion rate;Aneurysm recurrence rate;Aneurysm retreatment rate;Raymond-Roy grading of aneurysms at other follow-up times;Changes in mRS Scores from baseline; | — |
Countries
China
Contacts
Public ContactYuxiang Gu
Huashan Hospital affiliated to Fudan University
Outcome results
None listed