Choydar flow-directed mesh stent for unruptured brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, observational, real-world study of the Choydar flow-directed mesh stent used to treat unruptured intracranial aneurysms. Patients who already have a clinical decision to receive the device are enrolled and their treatments and outcomes are followed without randomization. Key preoperative inclusion criteria include aneurysms in the internal carotid (petrous to distal) or vertebral arteries with a neck ≥4 mm or dome-to-neck ratio <2 and parent artery diameter 2.0–6.0 mm. Outcomes of interest include device safety, aneurysm occlusion on imaging, and procedure-related complications over follow-up.

Why it matters

Who can join: the full rules

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 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's running

• Chenzhou No.1 People's Hospital
  Chenzhou, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, China Recruiting
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  Nanjing, China Recruiting
• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, China Recruiting
• Nanyang Central Hospital
  Nanyang, China Recruiting
• Shanxi Provincial People's Hospital
  Taiyuan, China Recruiting

Study contacts

• Study coordinator: Yuanyuan Gu
• Email: ygu51@its.jnj.com
• Phone: 86 15692105615

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flow Diverter Stent for Intracranial Aneurysm in China

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• Real-World Experience With the WEB Device for Intracranial Aneurysms

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• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

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• Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

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• Improving brain intervention planning using vascular mapping

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• Collecting real-life data on endovascular treatments for brain aneurysms

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  Recruiting Microvention-Terumo, Inc. · Vigo, Pontevedra · NCT06494436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.