Intracranial Non-saccular Aneurysms
Conditions
Keywords
intracranial non-saccular aneurysms
Brief summary
Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms.
Interventions
DEVICEflow diverter
the treatment of intracranial non-saccular aneurysms with flow diverter
Sponsors
RenJi Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1. Age 18 to 80 years, any gender 2. Diagnosed as a non-saccular aneurysm in the patient's intracranial region 3. Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form
Exclusion criteria
1. Aneurysm rupture within 30 days before enrollment; 2. Diagnosis of multiple aneurysms and requiring reoperation within 12 months 3. Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.); 4. Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.); 5. Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment; 6. Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs; 7. Known allergy to nickel-titanium alloy metal materials; 8. Life expectancy \<12 months; 9. Pregnant or breastfeeding women; 10. Subject has participated in other clinical trials within 1 month before signing informed consent; 11. Other conditions judged by the investigators as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete occlusion rate of aneurysm 12 months after surgery | 12 months after surgery | Complete occlusion is defined as no significant blood flow ,and achieves Raymond-Roy class I , which is diagnosed by cerebrovascular DSA at 6 months post-procedure. |
Outcome results
None listed