Actively Recruiting
Safety and Effectiveness Study of the Choydar Flow-Directed Mesh Stent for Treating Unruptured Intracranial Aneurysms
Led by Johnson & Johnson Medical (Shanghai) Ltd. · Updated on 2026-06-05
200
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Choydar Flow-Directed Mesh Stent in treating unruptured intracranial aneurysms, which are bulging blood vessels in the brain that have not ruptured. This observational study aims to gather real-world data on how well this stent works in patients with these aneurysms, focusing on treating wide-neck saccular or fusiform aneurysms in specific brain arteries. The study involves using the Choydar Flow-Directed Mesh Stent according to its official instructions in participants who have unruptured aneurysms in the internal carotid or vertebral arteries. Only this stent will be used for treatment, and no other interventions are part of the study. The stent is placed during a procedure guided by imaging techniques to treat the aneurysm. Participants will be monitored through follow-up visits over 12 months after the procedure. Researchers will assess outcomes such as the rate of complete and adequate aneurysm closure, technical success at the time of the procedure, need for additional treatments, functional status using a modified scale, and any major complications or vessel narrowing. The study tracks safety events during the procedure and throughout the year to understand long-term effects. Participants must be able to return for all follow-up visits as required.
CONDITIONS
Brief Title
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery
- Wide-neck saccular or fusiform aneurysms with neck width 4 mm or dome-to-neck ratio < 2
- Parent artery diameter between 2.0 mm and 6.0 mm
- Participants and/or authorized representatives understand the study and sign informed consent
- Clinical decision made to use the Choydar Flow-Directed Mesh Stent prior to enrollment
- Willingness and ability to attend all follow-up visits as required
- Confirmed presence of aneurysms meeting criteria by imaging (DSA, CTA, or MRA) during procedure
You will not qualify if you...
- Anatomy unsuitable for flow diverter passage or placement (e.g., excessively tortuous or tiny vessels, stenosis in target vessel, incomplete stent deployment)
- Allergy to contrast media
- Allergy to nickel-titanium alloy or platinum-tungsten alloy
- Contraindications to antiplatelet and/or anticoagulant therapy
- Active bacterial infection
- Confirmed pregnancy
- Participation in another investigational clinical study that may affect study endpoints (except observational or epidemiological studies)
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 - Day 0 (day of procedure)
Participants receive the Choydar Flow-Directed Mesh Stent procedure for treating unruptured intracranial aneurysms.
1 visit (in-person)
Duration - 12 months post-procedure
Participants are monitored for safety and effectiveness outcomes following the stent procedure.
Multiple follow-up visits during 12 months
Trial Site Locations
Total: 3 locations
1
Guangdong Provincial People's Hospital
Guangzhou, China, 519041
Actively Recruiting
2
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, China, 210008
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China, 450052
Actively Recruiting
Research Team
Y
Yuanyuan Gu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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