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一项关于Choydar血流导向网状支架治疗未破裂颅内动脉瘤的研究 (CROWN)

2026年11月2日更新者：Johnson & Johnson Medical (Shanghai) Ltd.

一项多中心、前瞻性、单臂观察性研究，旨在评估Choydar血流导向网状支架治疗未破裂颅内动脉瘤的安全性与有效性

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.

研究概览

地位

招聘中

条件

颅内动脉瘤

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Yuanyuan Gu
电话号码：86 15692105615
邮箱：ygu51@its.jnj.com

学习地点

中国
- - Chenzhou、中国、432000
    - 招聘中
    - Chenzhou No.1 People's Hospital
  - Guangzhou、中国、519041
    - 招聘中
    - Guangdong Provincial People's Hospital
  - Nanjing、中国、210008
    - 招聘中
    - Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  - Nanjing、中国、210029
    - 招聘中
    - The First Affiliated Hospital of Nanjing Medical University
  - Nanyang、中国、473000
    - 招聘中
    - Nanyang Central Hospital
  - Taiyuan、中国、30012
    - 招聘中
    - Shanxi Provincial People's Hospital
  - Wuhu、中国、241001
    - 招聘中
    - The First Affiliated Hospital of Wannan Medical College
  - Zhengzhou、中国、450052
    - 招聘中
    - The First Affiliated Hospital of Zhengzhou University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Choydar Flow-Directed Mesh Stent The choydar flow-directed mesh stent will be used in accordance to its Instructions For Use (IFU) in participants with unruptured intracranial aneurysms. Participants will not receive any other intervention as a part of this study.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I) 大体时间：At 12 months follow-up post-procedure	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 (%).	At 12 months follow-up post-procedure
Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II) 大体时间：At 12 months follow-up post-procedure	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 %.	At 12 months follow-up post-procedure
Percentage of Participants with Immediate Technical Success Rate of Procedure 大体时间：At Day 0 (Day 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 %.	At Day 0 (Day of procedure)
Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure 大体时间：At 12 months follow-up post-procedure	The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported.	At 12 months follow-up post-procedure
Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure 大体时间：At 12 months follow-up post-procedure	Percentage of participants with mRS score of 0-2 at 12 months post-procedure will be reported. The mRS score is issued to evaluate the improvement of neurological function. It assesses the ability of participants with neurological disease to live independently. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of participants , and 6 points represent death.	At 12 months follow-up post-procedure
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period 大体时间：Perioperative	Number of participants with major ischemic/hemorrhagic events and/or death during perioperative period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the National Institutes of Health Stroke Scale (NIHSS) score compared with the previous score.	Perioperative
Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up 大体时间：At 12 months follow-up post-procedure	Number of participants with major ischemic/hemorrhagic events and/or death during 12 months follow-up period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the NIHSS score compared with the previous score.	At 12 months follow-up post-procedure
Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up 大体时间：At 12 months follow-up post-procedure	Number of participants with severe in-stent stenosis during 12-month follow-up period will be reported. The percent stenosis is calculated according to the calculation method of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study as follows: (1 - Ds [Diameter of the artery at the site of the most severe stenosis]/Dn [Diameter of the normal artery]) * 100%.	At 12 months follow-up post-procedure
Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure 大体时间：At 12 months follow-up post-procedure	The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported.	At 12 months follow-up post-procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johnson & Johnson Medical (Shanghai) Ltd.

调查人员

研究主任：Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial、Johnson & Johnson Medical (Shanghai) Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月28日

初级完成 (估计的)

2028年2月10日

研究完成 (估计的)

2028年2月10日

研究注册日期

首次提交

2025年11月13日

首先提交符合 QC 标准的

2025年11月13日

首次发布 (实际的)

2025年11月14日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日