intracranial aneurysm
Conditions
Interventions
Test group:Flow modulation device
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years, male or female; 2. Patients diagnosed as intracranial aneurysms by brain CTA/MRA/DSA; 3. Patients with unruptured saccular aneurysms or fusiform aneurysm of internal carotid and vertebral arteries, who are clinically determined to use flow modulation device for endovascular treatment; 4. The diameter of the target aneurysm parent vessel was 1.75-5mm; 5. Patients target aneurysm is planned to be embolized using flow guide devices only; 6. The mRS Score of the patients was 0-2; 7. Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment. 2. Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography. 3. Patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery. 4. Complicated posterior circulation aneurysms or bifurcation aneurysms. 5. Patients with target aneurysm treated with stent or shunt before enrollment. 6. Known to be allergic to Nitinol platinum alloy and angiographic agents. 7. Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation. 8. Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma. 9. Patients undergoing craniotomy. 10. Serious infection is not controlled and is not suitable for operation. 11. Patients who underwent major surgery or interventional therapy (such as cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery. 12. Obvious abnormal coagulation function or bleeding tendency. 13. Severe respiratory insufficiency (PO250mmHg, i.e. 6.5Kpa); Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or elevated alanine aminotransferase (ALAT) more than 3 times the upper normal limit; 14. Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period. 15. Participation in any other clinical trial within 30 days prior to signing informed consent. 16. Other conditions considered by the investigator to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete aneurysm occlusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Good clinical prognosis rate;The incidence of in-stent restenosis;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactHongqi Zhang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed