Aneurysms
Conditions
Brief summary
Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.
Interventions
DEVICENo intervention measures
No intervention measures, Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years, any gender，Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms 2. Diagnosed with an intracranial aneurysm by CTA, MRA, or DSA, with the following features: a wide neck (≥4mm), or a dome-to-neck ratio \<2, saccular, fusiform aneurysms, recurrent saccular aneurysms, and dissecting aneurysms. Locations include: the Circle of Willis and it's distal branches such as the middle cerebral artery (MCA) M1-M3 segments, anterior cerebral artery (ACA) A1-A3 segments, posterior cerebral artery (PCA) P1-P2 segments, etc. (intracranial aneurysms of the Circle of Willis and it's distal vessels). 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. 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.) 2. mRS score ≥3 3. 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.) 4. Platelet count \<60×10\^9/L, known platelet dysfunction, or international normalized ratio (INR) \>1.5 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. Pregnant or breastfeeding women 8. Subject has participated in other clinical trials within 1 month before signing informed consent 9. Other conditions judged by the investigators as unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete occlusion rate of aneurysm 12 months after surgery | 12 months after surgery |
Countries
China
Contacts
CONTACTyuanyuan Shen
Outcome results
None listed