A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms

Recruiting now

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID: NCT07228312
Run by: Johnson & Johnson Medical (Shanghai) Ltd.
People needed: 200
Starts: 2026-01-28
Expected to finish: 2028-02-10
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Participants meeting any of the following exclusion criteria will be excluded:
Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed)
Participants who are allergic to contrast media
Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy
Participants who are contraindicated for antiplatelet and/or anticoagulant therapy
Participants with active bacterial infections
Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care
Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and/or epidemiological studies that do not require interventions)

Where it is running

Chenzhou No.1 People's Hospital — Chenzhou, China (enrolling)
Guangdong Provincial People's Hospital — Guangzhou, China (enrolling)
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, China (enrolling)
The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)
Nanyang Central Hospital — Nanyang, China (enrolling)
Shanxi Provincial People's Hospital — Taiyuan, China (enrolling)
The First Affiliated Hospital of Wannan Medical College — Wuhu, China (enrolling)
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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