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

Not yet recruiting

• Conditions: Intracranial Non-saccular Aneurysms

• Registration Number: NCT07205302
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-08
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.