A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms (NCT07228312) | Clinical Trial Compass
RecruitingNot Applicable
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
China200 participantsStarted 2026-01-28
Plain-language summary
The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Participants meeting all the following inclusion criteria will be included:
Preoperative inclusion criteria:
* Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to \[\>=\] 4 millimeters \[mm\] or dome-to-neck ratio less than \[\<\] 2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and less than or equal to \[\<=\] 6.0 mm
* Participants and/or their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF)
* Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent
* Participants who are willing and able to return for all follow-up visits as required by the study protocol
Intraoperative inclusion criteria:
\- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width \>= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and \<= 6.0 mm
Exclusion criteria:
Participants meeting any of the following exclusion c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)
Timeframe: At 12 months follow-up post-procedure
2
Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II)
Timeframe: At 12 months follow-up post-procedure
3
Percentage of Participants with Immediate Technical Success Rate of Procedure
Timeframe: At Day 0 (Day of procedure)
4
Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure
Timeframe: At 12 months follow-up post-procedure
5
Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure
Timeframe: At 12 months follow-up post-procedure
6
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period
Timeframe: Perioperative
7
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up