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

NCT ID: NCT07205302

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-08
• Study Completion Date: 2028-12-31

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.

Conditions

Intracranial Non-saccular Aneurysms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

FD

treatment of intracranial non-saccular aneurysms with flow diverter

flow diverter

Intervention Type: DEVICE

the treatment of intracranial non-saccular aneurysms with flow diverter

Interventions

flow diverter

the treatment of intracranial non-saccular aneurysms with flow diverter

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RJSW202504

Identifier Type: -

Identifier Source: org_study_id