Safety and Efficacy of the Flow Diverter in the Treatment of Intracranial Non-saccular Aneurysm (SAEFD)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Intracranial Non-saccular Aneurysms

Treatments: Device: flow diverter

Study type: Observational

Funder types: Other

Identifiers

NCT07205302

RJSW202504

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

168 participants in 1 patient group

FD

Description:

treatment of intracranial non-saccular aneurysms with flow diverter

Treatment:

Device: flow diverter