intracranial aneurysm
Conditions
Interventions
case series:flow diverter device
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, no gender limitation; 2. Patients diagnosed with untreated, unruptured intracranial aneurysm by CTA, MRA or DSA; 3. The diameter range of parent artery was 2.0-6.5 mm; 4. Target aneurysms can be treated with interventional therapy in a single operation; 5. The subject or his/her legal guardian agrees to participate in the study and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Craniotomy or other cerebrovascular intervention within the previous 30 days; 2. The target aneurysm has been treated with stenting at the site of the aneurysm-carrying artery; 3. The presence of intracranial aneurysms other than the target aneurysm that require surgical treatment within 12 months of the operation; 4. The presence of severe entrapment in the vascular pathway, or extreme tortuosity, or severe cerebral vasospasm, or stenosis greater than 50% due to atherosclerosis, making it difficult for the test instrument to reach the site of the lesion; 5. Aneurysm bleeding within 60 days prior to surgery; 6. Modified Rankin Score (mRS) >= 4; 7. Where the target aneurysm is a pseudoaneurysm, or an aneurysm associated with an arteriovenous malformation or smouldering disease; 8. Patients who are unable to receive anti-platelet drugs and/or anticoagulation; 9. Patients with known clear allergy to cobalt-chromium-platinum alloys, contrast agents; 10. Patients with known dementia or mental illness who are unable to cooperate with the test; 11. Preoperative comorbidities of known serious cardiac, hepatic, renal and respiratory disease and dyscoagulable disorders; 12. Life expectancy of less than 1 year; 13. Patients who are participating in clinical trials of other drugs or medical devices and have not reached the trial endpoint; 14. Women who are pregnant or breastfeeding or who have a positive pregnancy test; 15. There are other conditions that the investigator considers inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete occlusion of target aneurysm at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Rate of complete occlusion of target aneurysm at 6 months after surgery;Clinical success rate at 12 months after surgery;Postoperative aneurysm-carrying artery patency rate at 12 months;Proportion of positive neurological function at 12 months post-operatively;Intraoperative instrument performance evaluation;Safety evaluation; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Outcome results
None listed