Choydar flow-directed mesh stent for unruptured brain aneurysms

A Multicenter, Prospective, Single-Arm Observational Study to Evaluate the Safety and Effectiveness of the Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms

This trial tests the Choydar flow-directed mesh stent to see if it is safe and works for people with unruptured intracranial aneurysms in the internal carotid or vertebral arteries.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johnson & Johnson Medical (Shanghai) Ltd. (industry)
• Locations: 3 sites (Guangzhou and 2 other locations)
• Trial ID: NCT07228312 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with unruptured saccular or fusiform aneurysms in the specified segments of the internal carotid or vertebral arteries who have a clinical plan to receive the Choydar stent and can provide informed consent.

Not a fit: Patients with ruptured aneurysms, aneurysms outside the specified artery segments, parent artery diameters outside 2.0–6.0 mm, or those not treated with the Choydar device are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could offer a safer or more effective option for treating certain unruptured intracranial aneurysms and reduce the risk of future rupture.

How similar studies have performed: Flow-diverting and mesh stent approaches have shown positive results in prior aneurysm series, but device-specific data for the Choydar stent are limited and this study aims to add real-world evidence.

Eligibility criteria

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. The aneurysm must have a neck width greater than or equal to (\>=) 4 millimeters (mm) or a dome-to-neck ratio less than (\<) 2, and the parent artery diameter must be \>= 2.0 mm and less than or equal to (\<=) 6.0 mm, including saccular and fusiform aneurysms
* 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. The aneurysm must have a neck width \>= 4 mm or a dome-to-neck ratio \< 2, and the parent artery diameter must be \>= 2.0 mm and \<= 6.0 mm, including saccular and fusiform aneurysms

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 this trial is running

Guangzhou and 2 other locations

• 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 Zhengzhou University — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Yuanyuan Gu

Conditions: Intracranial Aneurysm