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

Official title

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

Overview

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.

Primary outcome measures

• Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I) [Time frame: At 12 months follow-up post-procedure]
• Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II) [Time frame: At 12 months follow-up post-procedure]
• Percentage of Participants with Immediate Technical Success Rate of Procedure [Time frame: At Day 0 (Day of procedure)]
• Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure [Time frame: At 12 months follow-up post-procedure]
• Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure [Time frame: At 12 months follow-up post-procedure]
• Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period [Time frame: Perioperative]
• Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up [Time frame: At 12 months follow-up post-procedure]
• Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up [Time frame: At 12 months follow-up post-procedure]
• Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure [Time frame: At 12 months follow-up post-procedure]

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, 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 8 centers

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

Identifiers

NCT: NCT07228312 · CNV202507

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗