intracranial aneurysm
Conditions
Interventions
Experimental group:MeshCoil Aneurysm Closure Device Implantation
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients diagnosed by CTA, MRA or DSA with intracranial aneurysm requiring treatment; 3. The target aneurysm must meet the following characteristics: (1) The aneurysm is located at the bifurcation of the intracranial blood vessels; (2) The tumor is cystic; (3) Tumor body/tumor neck ratio >= 1; (4) Wide-necked aneurysm (tumor neck >=4mm or tumor body/tumor neck ratio <2); 4. If there are multiple aneurysms, only one of them is selected as the target aneurysm for treatment, and the other aneurysms will be treated after 60 days after surgery; 5. The patient agrees and signs the informed consent, and must be willing and able to cooperate with the postoperative follow-up required in this study.
Exclusion criteria
Exclusion criteria: 1. Severe arteriosclerosis, or extremely tortuous parent blood vessels, it is difficult for the test device to reach the target position; 2. Patients with vasospasm, vasculitis, intracranial tumors or other intracranial vascular malformations; 3. Modified Rankin score ( mRS) >= 2; 4. The target aneurysm has recurred after embolization or clipping; 5. Patients who need other intracranial vascular disease surgery at the same time; 6. Patients who are allergic to materials such as contrast agents, nickel-titanium metal or its alloys; 7. Patients with intracranial hemorrhage within 90 days; 8. Ischemic events occurred within 60 days, such as TIA, stroke; 9. Patients with known contraindications to antiplatelet or/and anticoagulation therapy; 10. Serious blood diseases, known coagulation disorders, excessive blood viscosity and other blood problems; 11. Patients with severe liver and kidney dysfunction (ALT>3 times the upper limit of normal; creatinine>450umol/L); 12. Have serious heart disease and other life-threatening diseases; 13. Patients with mental illness cannot cooperate with screening and follow-up; 14. Pregnant or breastfeeding patients, women who have a childbearing plan within 1 year or who are unwilling to take effective contraceptive measures; 15. Patients with life expectancy less than 1 year; 16. Participating in other drug or device clinical trials and failing to reach the primary endpoint; 17. Patients judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: 12-month postoperative aneurysm treatment success rate;Safety: 12-month postoperative major adverse event (MAE) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant placement success rate;Immediate operative success rate;Stroke rate, mortality;Primary patency rate of the aneurysm parent artery;The incidence of device-related adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Xuanwu Hospital of Capital Medical University
Outcome results
None listed