Intracerebral aneurysm
Conditions
Interventions
Test group:Shanghai Lee Kai Cyllene intracranial vascular stent used with spring coil
Control group:Stryker Neuroform Atlas stent system used with spring coil
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. =18 years old and =80 years old; 2. Unruptured anterior circulation intracranial wide-necked aneurysm (neck =4mm or body-neck ratio < 2) with parent artery diameter =2mm or =4.5mm; 3. Preoperative modified Rankin score (mRS) =2 points; 4. Subjects who voluntarily participate in and sign written informed consent and can accept the examination and follow-up prescribed by the program.
Exclusion criteria
Exclusion criteria: 1.Fusiform aneurysms, dissection aneurysms, pseudoaneurysms, vesicular aneurysms, infectious aneurysms, arteriovenous malformation related aneurysms, moyamoya disease related aneurysms; 2. The target aneurysm has previously received vascular embolization or stent implantation; 3. Complicated with space-occupying lesions such as intracranial hematoma or brain tumor unrelated to the target aneurysm; 4. Severe intracranial artery stenosis or tortuosity, or anatomical abnormalities, estimated that it is difficult to reach the lesion site; 5. Patients who plan to receive treatment for other intracranial lesions within one year; 6. Multiple aneurysms that cannot be completely covered by the same stent; 7. Platelet (PLT)<60×109/L or/and anticoagulation, antiplatelet therapy contraindoed; 8. Subjects who did not take antiplatelet drugs before stent implantation; 9. The subject has a clear history of allergies to Nitinol and platinum-iridium alloys; 10. Contraindicated angiography, MRI, CT; 11. Evidence of active infection; 12. Subjects with an estimated life expectancy of less than 12 months could not complete the study follow-up; 13. Women who are pregnant or breastfeeding, or who plan to give birth within the next year; 14. The researchers judged that it was not suitable to use intracranial vascular stents for the embolization of intracranial aneurysms; 15. Participating in the study of other drugs or devices; 16. Subject is unable to cooperate in completing the required examination and follow-up or for other conditions deemed unsuitable for inclusion by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful occlusion of target aneurysms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of successful aneurysm occlusion immediately after surgery;Technical success rate of stent;Rate of intrastent stenosis;Re-treatment rate of target aneurysms after surgery;Aneurysm complete occlusion rate;Grade of mRS;Instrument operation performance evaluation; | — |
Countries
China
Contacts
Public ContactLiu jianmin
Shanghai Changhai Hospital
Outcome results
None listed