Actively Recruiting
Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms
Led by Huashan Hospital · Updated on 2025-08-29
523
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
X
Xinqiao Hospital of Chongqing
Collaborating Sponsor
AI-Summary
What this Trial Is About
To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.
CONDITIONS
Official Title
Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed intracranial aneurysm by CTA, MRA, or DSA
- Aneurysm types include wide-necked, saccular, fusiform, recurrent saccular, and dissecting aneurysms
- Parent vessel diameter between 2.0 mm and 6.0 mm
- Aneurysm location includes anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery, basilar artery, and main branches
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Aneurysms related to arteriovenous malformation (AVM)
- Acute ruptured aneurysm
- Severe stenosis or tortuosity of intracranial arteries making device delivery difficult
- Hemorrhagic or ischemic stroke within 30 days
- Modified Rankin Score greater than 2 before operation
- Life expectancy less than 12 months
- Known allergy to cobalt-chromium or platinum-tungsten alloys, or contrast media
- Platelet count less than 100 x 10^9/L or contraindication to anticoagulation
- Pregnant or lactating women
- Other conditions deemed unsuitable by the investigator
- Intraoperative exclusion: acute aneurysm rupture/hemorrhage during surgery, failure of FD implantation, thrombosis in stent, or stent mal-apposition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
G
Gao Chao, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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