Intracranial aneurysm
Conditions
Interventions
Experimental group:Endosaccular Flow Disruption Implantation
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The age of the subjects = 18 years old, and = 80 years old, no gender limit; (2) For ruptured or unruptured intracranial cystic aneurysms, the ratio of aneurysm body width to aneurysm neck width = 1 under DSA angiography, and it is suitable for embolization and interventional treatment; (3) Subjects are willing to comply with protocol requirements and data collection procedures, understand and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe arteriosclerosis of the target vessel, extreme tortuosity or severe stenosis of the aneurysm carrier vessel, or severe cerebral vasospasm, or anatomical factors that make it difficult for the study device to reach the lesion or unsuitable for implantation of the study device; (2) The target aneurysms are spindle shaped aneurysms, dissecting aneurysms, pseudoaneurysms, infectious aneurysms or arteriovenous malformations, and aneurysms associated with Moyamoya disease; Patients with recurrent target aneurysms who have had coil or stent implantation; (3) Preoperative mRS score = 3 points; (4) Hunt rating = Level IV; (5) Severe liver or renal dysfunction (ALT>3 times the upper normal limit; creatinine>225 µ mol/L); Uncontrolled severe hypertension (systolic blood pressure>180 mmHg or diastolic blood pressure>115 mmHg); Those who have serious reactions to anesthetic drugs or contrast agents and are unable to complete surgical medication; Patients with a clear history of nickel titanium alloy allergy; (6) Anti platelet (PLT)<60×10^9/L, or patients with active bleeding who cannot receive antiplatelet aggregation or anticoagulation therapy; (7) Patients who are participating in other clinical trials or intervention studies that may affect the efficacy or safety of the study device but have not reached the primary study endpoint; (8) Pregnant or lactating women, or patients who plan to become pregnant within 1 year; (9) Patients with diseases that can cause difficulties in treatment and evaluation (such as dementia or mental disorders, infections, severe metabolic diseases, etc.) and estimated life expectancy of less than 3 years; Patients who have planned to undergo major surgery within 1 month; (10) Investigators have judged poor compliance, unable to complete follow-up as required, and other cases that clinicians believe should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month postoperative aneurysm occlusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month postoperative aneurysm recurrence rate;12-month postoperative target lesion retreatment rate;Device technical success rate;Release success rate;Device defects; | — |
Countries
China
Contacts
Public ContactYang Xinjian
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed