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
17 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
Researchers are evaluating the clinical safety and effectiveness of Flow Diverters (FD) in treating intracranial aneurysms. This study aims to confirm how well FD works for aneurysms of different shapes and locations, optimize postoperative medication, and build a large database to support long-term treatment decisions. The trial will include 523 patients across multiple centers, focusing on real-world use of FD as a minimally invasive treatment to promote aneurysm healing. Participants will receive FD treatment, which works by changing blood flow to encourage clotting within the aneurysm and help repair blood vessels. This single-arm, prospective study involves follow-up evaluations at multiple time points, including 6 and 12 months after surgery. The study will assess aneurysm closure rates, success of the procedure, and any complications such as stroke or vessel narrowing. Researchers will also analyze surgery success rates and the need for retreatment. During the study, participants will undergo imaging tests like cerebral angiography and clinical assessments to monitor aneurysm healing and neurological function. Safety will be closely tracked through recording adverse events and neurological outcomes. Quality of life and functional recovery will also be evaluated. The entire participation period includes long-term follow-up to provide evidence supporting the use of FD and improving patient outcomes.
CONDITIONS
Brief 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 with 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 located in anterior circulation C3 segment and above of internal carotid artery, distal arteries of Willis circle, posterior circulation V4 segment of vertebral artery, basilar artery and its main branches
- Voluntary participation and 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 artery or anatomical abnormalities preventing device delivery
- Hemorrhagic or ischemic stroke within 30 days prior to study
- Modified Rankin Score greater than 2 before operation
- Life expectancy less than 12 months
- Known allergy to cobalt-chromium alloy, platinum-tungsten alloy materials, or contrast media
- Platelet count below 100 x 10^9/L or contraindications to anticoagulation
- Pregnant or lactating women
- Other conditions deemed unsuitable by the investigator
- Intraoperative exclusions include acute rupture or hemorrhage during operation, failure of Flow Diverter implantation, thrombosis in stent, or stent mal-apposition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Immediate perioperative period
Participants undergo Flow Diverter implantation surgery to treat intracranial aneurysms and receive immediate care after surgery.
1 surgical visit and immediate post-operative monitoring
Duration - 12 months after surgery
Participants are monitored with clinical imaging and neurological assessments to evaluate aneurysm occlusion, complications, and recovery.
Visits at 3 months, 6 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Huashan hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
G
Gao Chao, PhD
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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