比较两种不同支架系统治疗颅内动脉瘤的安全性和有效性
2026年7月9日 更新者：Sinomed Neurovita Technology Inc.
一项评估 SINOMED IAS 治疗颅内动脉瘤安全性和有效性的前瞻性、多中心、随机对照试验
本试验的主要目的是评估 SINOMED IAS 在颅内动脉瘤患者中的安全性和有效性。
研究概览
详细说明
本研究是一项前瞻性、多中心、1:1随机临床试验，旨在评估支架系统治疗颅内动脉瘤的安全性和有效性。
计划总共纳入 204 名患者。
主要终点是术后 6 个月动脉瘤闭塞成功的发生率。
所有患者均在术中、30天、6个月、1年期间进行临床随访。
研究类型
介入性
注册 (实际的)
203
阶段
- 不适用
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。
学习地点
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Beijing、中国
- Beijing Tiantan Hospital, Capital Medical University
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Chengdu、中国
- West China Hospital of Sichuan University
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Guiyang、中国
- The Affiliated Hospital of Guizhou Medical University
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Harbin、中国
- The First Affiliated Hospital of Harbin Medical University
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Jilin City、中国
- The First Hospital of Jilin University
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Jinhua、中国
- Jinhua Central Hospital
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Nanchang、中国
- The First Affiliated Hospital of Nanchang University
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Nanjing、中国
- Affiliated Drum Tower Hospital, Medical School of Nanjing University
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Nanjing、中国
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
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Tangdu、中国
- The Second Affiliated Hospital of the Air Force Medical University (Tangdu Hospital of Fourth Military Medical University)
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Wuhu、中国
- The First Affiliated Hospital of Wannan Medical University
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Xinjiang、中国
- The First Affiliated Hospital of Xinjiang Medical University
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Zhengzhou、中国
- Henan Provincial People's Hospital
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Zhujiang、中国
- ZhuJiang Hospital of Southern Medical University
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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
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 年龄18岁至80岁。
- 宽颈（宽颈定义为宽度≥ 4 mm 或圆顶与颈比< 2）、囊状、颅内动脉瘤，源自直径≥ 2.5 mm 且≤ 5 mm 的载瘤血管。
- 改良兰金量表 (mRS) ≤ 2。
- 受试者了解程序的性质，在治疗前提供自愿的书面知情同意书，并愿意遵守指定的后续评估。
- 研究人员判断使用支架辅助弹簧圈栓塞术适合治疗颅内动脉瘤。
排除标准：
- 目标动脉瘤是需要分期手术的动脉瘤。
- 先前已通过血管栓塞或手术治疗的目标动脉瘤。
- 目标动脉瘤是梭形动脉瘤、夹层动脉瘤、假性动脉瘤、血泡样动脉瘤、感染性动脉瘤、与动静脉畸形相关的动脉瘤。
- 术前30天内住院手术治疗，或术后6个月内计划住院手术治疗。
- 入组后 14 天内动脉瘤急性破裂。
- 亨特和赫斯 (H&H) 量表≥3。
- 患有烟雾病、动静脉畸形、动静脉瘘、颅内肿瘤或与目标动脉瘤相关的颅内肿块的受试者。
- 颅内动脉严重狭窄或迂曲或解剖异常，导致装置难以到达病变部位。
- 血小板计数 <50*103/mm3 (50*109/L) 或任何已知的凝血缺陷，或国际标准化比值 (INR)>3.0。
- 已知对造影剂、支架组件、抗血小板、抗凝剂过敏/过敏或禁忌。
- 预期寿命<1年，且无法完成规定的随访；
- 怀孕或哺乳的女性、计划在明年生育孩子的女性/男性。
- 目前正在参加另一项研究设备或药物研究。
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SINOMED IAS 支架系统
SINOMED IAS 支架系统旨在与闭塞装置一起使用，治疗颅内动脉瘤。
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颅内动脉瘤的支架辅助弹簧圈栓塞（SAC）为宽颈动脉瘤的血管内弹簧圈栓塞铺平了道路，提高了动脉瘤的闭塞率和复发率。
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有源比较器：Neuroform Atlas 支架系统
Neuroform Atlas 支架系统旨在与闭塞装置一起使用，治疗颅内动脉瘤。
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颅内动脉瘤的支架辅助弹簧圈栓塞（SAC）为宽颈动脉瘤的血管内弹簧圈栓塞铺平了道路，提高了动脉瘤的闭塞率和复发率。
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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 |
|---|---|---|
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The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure
大体时间：12 months post-procedure
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Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 12 months.
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12 months post-procedure
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The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure
大体时间：12 months post-procedure
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National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42.
Higher values represent a worse outcome.
A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.
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12 months post-procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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技术上的成功
大体时间：程序内
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技术成功定义为稳定的支架放置，完全覆盖动脉瘤颈和载瘤动脉通畅。
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程序内
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Complete aneurysm occlusion or success aneurysm occlusion immediately after the procedure
大体时间：Immediately after the procedure
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Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (grade I).
Success aneurysm occlusion was as defined by grade I (complete obliteration) and II (residual neck).
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Immediately after the procedure
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Success aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 12 months post procedure
大体时间：12 months post procedure
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Proportion of subjects with success occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target intracranial aneurysms (IA) at 12 months as assessed by angiography, and in whom an unplanned alternative treatment of the target IA had not been performed within 12 months.
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12 months post procedure
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Complete aneurysm occlusion or success aneurysm occlusion at 12 months post procedure
大体时间：12 months post procedure
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Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (grade I).
Success aneurysm occlusion was as defined by grade I (complete obliteration) and II (residual neck).
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12 months post procedure
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Retreatment Rate at 6 months and 12 months post procedure
大体时间：6 months, 12 months post procedure
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The percentage of target aneurysms that are retreated at any time up to and including the 6 months and 12 months follow-up visit will be evaluated.
Retreatment will be defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), and (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.
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6 months, 12 months post procedure
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In-Stent Stenosis at 12 months post procedure
大体时间：12 months post procedure
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In-stent stenosis defined as greater than 50% narrowing of the vessel within the stent or within 5mm of either end of the stent.
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12 months post procedure
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Modified Rankin Scale (mRS) at 30 days, 6 months and 12 months post procedure
大体时间：30 days, 6 months, 12 months post procedure
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Observed scores on the Modified Rankin Scale will be presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure).
The number and percentage of subjects who have an mRS ≤ 2 will be evaluated.
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30 days, 6 months, 12 months post procedure
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Major ipsilateral stroke or neurogenic death at 30 days, 6 months post procedure
大体时间：30 days, 6 months post procedure
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National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42.
Higher values represent a worse outcome.
A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.
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30 days, 6 months post procedure
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All-cause mortality at 30 days, 6 months and 12 month post procedure
大体时间：30 days, 180 days and 12 months post procedure
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Deaths due to any cause are calculated.
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30 days, 180 days and 12 months post procedure
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Incidence of adverse events/serious adverse events during 30 days, 6 months and 12 month post procedure
大体时间：30 days, 6 months and 12 months post procedure
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Percentage (%) of participants who experienced adverse events/serious adverse events.
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30 days, 6 months and 12 months post procedure
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In-stent thrombosis at 12 months post procedure
大体时间：12 months post procedure
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Stent thrombosis defined as a thrombotic occlusion of a stent.
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12 months post procedure
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Rate of Device defect
大体时间：within 12 months of whole trial
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Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.
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within 12 months of whole trial
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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。
调查人员
- 首席研究员：xinJian Yang、Beijing Tiantan Hospital
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)
2024年1月17日
初级完成 (实际的)
2025年11月20日
研究完成 (实际的)
2025年11月20日
研究注册日期
首次提交
2024年3月4日
首先提交符合 QC 标准的
2024年3月4日
首次发布 (实际的)
2024年3月12日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.