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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohnson & Johnson Medical (Shanghai) Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 1 trial group