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Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

2022年5月4日 更新者：Suzhou Hengruihongyuan Medical Technology Co. LTD

A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.

研究类型

介入性

注册 (预期的)

116

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

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国
        • 尚未招聘
        • Guangdong Provincial People's Hospital
        • 接触：
          • Dong Zhou
      • Guangzhou、Guangdong、中国、510280
        • 尚未招聘
        • Zhujiang Hospital of Southern Medical University
        • 接触：
          • Chuanzhi Duan
      • Guangzhou、Guangdong、中国、510515
        • 尚未招聘
        • Nan Fang Hospital
        • 接触：
          • Songtao Qi
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • 尚未招聘
        • The First Affiliated Hospital of Harbin Medical University
        • 接触：
          • Huaizhang Shi
    • Henan
      • Zhengzhou、Henan、中国
        • 招聘中
        • Henan provincial people's hospital
        • 接触：
          • Tianxiao Li
    • Hubei
      • Wuhan、Hubei、中国、430071
        • 尚未招聘
        • Zhongnan Hospital of Wuhan University
        • 接触：
          • Jincao Chen
    • Jiangsu
      • Changzhou、Jiangsu、中国
        • 尚未招聘
        • The First People's Hospital of Changzhou
      • Nanjing、Jiangsu、中国、210008
        • 尚未招聘
        • Nanjng Drum Tower Hospital
        • 接触：
          • Chunhua Hang
      • Nanjing、Jiangsu、中国
        • 尚未招聘
        • General Hospital of eastern theater command
        • 接触：
          • HanDong Wang
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • 尚未招聘
        • The Second Affiliated Hospital of Nanchang University
        • 接触：
          • Xingen Zhu
    • Shanghai
      • Shanghai、Shanghai、中国
        • 招聘中
        • Shanghai Changhai Hospital
        • 接触：
          • Jianmin Liu, Doctor
      • Shanghai、Shanghai、中国
        • 尚未招聘
        • Huashan Hospital ,Fudan University
        • 接触：
          • Yuxiang Gu, Doctor
    • Zhejiang
      • Hangzhou、Zhejiang、中国、322000
        • 尚未招聘
        • The second affiliated hospital of zhejiang university school of medicine
        • 接触：
          • Jianmin Zhang

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 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18-70 years old, no gender limit.
  2. The patient was diagnosed as cerebral arteriovenous malformation .
  3. The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
  4. Spetzler Martin, grade I-IV .
  5. The patient voluntarily signed the informed consent.

Exclusion Criteria:

  1. History of heparin allergy.
  2. The patient is allergic to contrast media.
  3. Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
  4. Patient has irreversible coagulopathy (INR > 1.5).
  5. Intracranial hemorrhage 1 week before treatment.
  6. MRS ≥4 due to neurological dysfunction.
  7. Patients with planned malformation resection after embolization.
  8. Blood flow related aneurysms of supplying artery that need to be treated by other methods.
  9. Complicated with severe cerebral artery stenosis.
  10. Brain tumors that require recent surgery.
  11. Complicated with proliferative cerebrovascular disease.
  12. Pregnant or lactating women.
  13. Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
  14. The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
  15. Subjects deemed unsuitable for this study by the investigator.

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
实验性的：Non-adhesive Liquid Embolic System(NALES)
设备：embolism
Cerebral arteriovenous malformation embolism
有源比较器：Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
设备：embolism
Cerebral arteriovenous malformation embolism

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
Effective embolization rate of malformed masses
大体时间：Immediately after surgery
Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.
Immediately after surgery

次要结果测量

结果测量
措施说明
大体时间
MRS score
大体时间：1,6,12months after surgery
MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge .
1,6,12months after surgery
Technical success rate
大体时间：Immediately after surgery
Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body
Immediately after surgery
Catheter performance evaluation
大体时间：Immediately after surgery
  1. The ability of the catheter to reach the lesion .
  2. The catheter has broken at the tip and perforated.
  3. Intravascular complications associated with catheters occurred.
  4. Degree of difficulty in tube withdrawal
  5. Catheter jam
Immediately after surgery

其他结果措施

结果测量
措施说明
大体时间
Incidence of major adverse events related to device or surgical procedures within 1 month after surgery
大体时间：1 month after surgery
Major adverse events related to instrumentation or surgical procedures within 1 month after surgery: bleeding during embolization, catheter indwelling, bleeding after embolization, symptomatic cerebral infarction, and edema.
1 month after surgery

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

Suzhou Hengruihongyuan Medical Technology Co. 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)

2021年12月2日

初级完成 (预期的)

2023年10月17日

研究完成 (预期的)

2024年10月17日

研究注册日期

首次提交

2021年9月24日

首先提交符合 QC 标准的

2021年9月24日

首次发布 (实际的)

2021年9月27日

研究记录更新

最后更新发布 (实际的)

2022年5月6日

上次提交的符合 QC 标准的更新

2022年5月4日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Nal01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Taiwan

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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