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

This trial does not accept healthy volunteers

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 population

Adult participants with unruptured wide-neck (neck width \>= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter \>= 2.0 mm and \<= 6.0 mm.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Choydar Flow-Directed Mesh Stent

Trial outcomes

Primary outcomes

1

Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I)

Complete aneurysm occlusion rate as per Raymond Roy classification criteria (Class I) is defined as complete obliteration (no contrast filling in aneurysm body or neck). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation \* 100 percent (%).

Time frame
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)

Adequate aneurysm occlusion rate as per Raymond Roy classification criteria (Class II and III) is defined as Class II: residual neck (contrast filling in aneurysm neck but none in aneurysm body) and Class III: residual aneurysm (contrast filling in aneurysm body). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I/II occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation \* 100 %.

Time frame
At 12 months follow-up post-procedure
3

Percentage of Participants with Immediate Technical Success Rate of Procedure

Percentage of participants with immediate technical success rate of procedure will be reported. Immediate technical success of the procedure is defined as the percentage of participants in whom the flow diverter is successfully deployed during the procedure, with accurate positioning confirmed by intra-procedure angiography, and with effective coverage of the aneurysm neck by the implant. It is calculated as follows: number of participants with successful placement of the investigational device/total number of participants undergoing the treatment \* 100 %.

Time frame
At Day 0 (Day of procedure)
4

Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure

The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported.

Time frame
At 12 months follow-up post-procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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