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

NCT07205302 | Not Yet Recruiting

• 1 other identifier: RJSW202504
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Keywords

intracranial non-saccular aneurysms

Outcome Measures

Primary Outcomes (1)

• Complete occlusion rate of aneurysm 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.

  12 months after surgery

Study Arms (1)

FD

treatment of intracranial non-saccular aneurysms with flow diverter

Device: flow diverter

Interventions

flow diverter DEVICE

the treatment of intracranial non-saccular aneurysms with flow diverter

FD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with intracranial Non-saccular aneurysm

You may qualify if:

• Age 18 to 80 years, any gender
• Diagnosed as a non-saccular aneurysm in the patient's intracranial region
• 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

You may not qualify if:

• Aneurysm rupture within 30 days before enrollment;
• Diagnosis of multiple aneurysms and requiring reoperation within 12 months
• 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.);
• 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.);
• Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment;
• Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs;
• Known allergy to nickel-titanium alloy metal materials;
• Life expectancy \<12 months;
• Pregnant or breastfeeding women;
• Subject has participated in other clinical trials within 1 month before signing informed consent;
• Other conditions judged by the investigators as unsuitable for enrollment.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09