Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms

Zhejiang University

Status: Enrolling

Conditions: Aneurysms

Treatments: Device: No intervention measures

Study type: Observational

Funder types: Other

Identifiers

NCT07376590

FESTR-DAN

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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