Intracranial aneurysm
Conditions
Interventions
FD group:Flow diverter treatment
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At the time of screening, the patient's age must be between 18 and 75 years old. 2. The patient must have an unbroken bifurcation of the middle cerebral artery (MCA) IA that requires treatment. If the patient still has other IA that require treatment, they cannot receive treatment within 60 days after the surgery in this study. 3. The target aneurysm to be treated must have the following characteristics: A: unruptured aneurysm located at the bifurcation of the middle cerebral artery (MCA); B:wide neck aneurysm: neck = 4mm or body neck ratio<2; 4. Target aneurysms are suitable for receiving FD or stent assisted coiling treatment. 5. Patients must comply with all requirements for screening, evaluation, treatment, and postoperative follow-up. 6. Patients must sign an informed consent form approved by IRB/EC and indicate the date before the start of the study operation.
Exclusion criteria
Exclusion criteria: 1. The patient's target IA is not suitable for endovascular treatment; 2. Merging adjacent parent artery stenosis; 3. Narrow neck target IA that can be treated solely with coil embolization; 4. Target IA that cannot be reached by microcatheters and cannot be treated with research device; 5. When using device, due to the patient's vascular characteristics, curvature, or shape, it is not possible to achieve safe transportation and support; 6. The patient has vascular malformations; 7. There are clinical symptoms, angiography or CT examination indicating that the patient has vasospasm, Vasculitis, intracranial tumors (excluding small meningiomas) or other intracranial vascular malformations; 8. The patient has high risk factors of ischemic stroke, or ischemic symptoms that have occurred in the past 60 days, such as Transient ischemic attack, stroke or progressive stroke; 9. The patient has any circulatory, cerebrovascular, cardiovascular or neurological diseases that can cause unstable neurological symptoms; 10. The patient has SAH or other intracranial hematoma caused by intracranial aneurysm within 90 days; 11. The patient has other physical, neurological, or mental conditions that may prevent them from completing screening, evaluation, treatment, and postoperative visits; 12. The patient's target IA has previously received treatment; 13. The patient is receiving Anticoagulant treatment, malignant disease of the blood system, Coagulopathy or hemoglobin disease; 14. Pregnancy of the patient; 15. The patient is allergic to any component of the research device, surgical materials or Drug allergy used during the operation and cannot be effectively treated; 16. Patients participating in other clinical or post market studies that may affect the safety and effectiveness of the research device in treating IA or affect research visits; 17. The patient has a life-threatening emergency situation outside of this study; 18. The patient's expected life is less than 2 years due to other diseases or conditions (excluding intracranial aneurysms). 19. Patients with mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete occlusion of aneurysm;The incidence of major adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate of aneurysms at 6 and 12 month follow-up;Coverage of branch vessel stenosis and occlusion ratio;The incidence of stent related cerebral ischemia; | — |
Countries
China
Contacts
Public ContactGuan Sheng
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed