ChiCTR2000036972 版本V1.3 版本创建时间2020/9/27 11:17:24 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000036972 

最近更新时间:

Date of Last Refreshed on:

2020/9/27 11:15:27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

支架辅助栓塞急性破裂脑动脉瘤安全性的关键技术研究 

Public title:

Key Techniques of Stent-assisted Coiling of Acute Ruptured Cerebral Aneurysm 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

支架辅助栓塞急性破裂脑动脉瘤安全性-多中心前瞻性临床观察研究 

Scientific title:

Stent-Assisted coiling of acutely ruptured cerebral aneurysm-multicenter prospectiVE registry (SAVE) 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

赵兵 

研究负责人:

赵兵 

Applicant:

Bing Zhao 

Study leader:

Bing Zhao 

申请注册联系人电话:

Applicant telephone:

+86 13601696475 

研究负责人电话:

Study leader's telephone:

+86 13601696475 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

bzns@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bzns@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市浦建路160号 

研究负责人通讯地址:

上海市浦建路160号 

Applicant address:

160 Pujian Road, Pudong New Area, Shanghai, China 

Study leader's address:

160 Pujian Road, Pudong New Area, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海交通大学医学院附属仁济医院 

Applicant's institution:

Renji Hospital, School of Medicine, Shanghai Jiaotong University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

SK2020-082 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海交通大学医学院附属仁济医院伦理委员会 

Name of the ethic committee:

Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committees 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-20 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

上海交通大学医学院附属仁济医院 

Primary sponsor:

Renji Hospital, School of Medicine, Shanghai Jiaotong University 

研究实施负责(组长)单位地址:

上海市浦建路160号 

Primary sponsor's address:

160 Pujian Road, Pudong New Area, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai Shenkang Hosptial Development Center 

研究疾病:

脑动脉瘤 

Target disease:

Cerebral Aneurysm 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

提高支架辅助栓塞急性破裂动脉瘤安全策略。 

Objectives of Study:

Improving the safety strategy of stent-assisted coiling of acutely ruptured cerebral aneurysms. 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 年龄18周岁-小于或等于75周岁; 2. 经脑血管DSA、CTA或MRA检查证实脑动脉瘤; 3. 头颅CT明确自发性蛛网膜下腔出血; 4. WFNS分级≤4级; 5. 破裂宽颈动脉瘤,瘤颈大约4mm或瘤体颈比≤2; 6. 发病0-72h小时行支架治疗; 7. 破裂责任动脉瘤行支架辅助栓塞治疗; 8. 患者和家属签署知情同意书。 

Inclusion criteria

1. Aged 18 years - less than or equal to 75 years; 2. Cerebral aneurysm confirmed by DSA, CTA or MRA; 3. Spontaneous subarachnoid hemorrhage confirmed by head CT; 4. WFNS grade <= 4 grade; 5. Ruptured wide-necked aneurysm, the neck more than 4mm, or the dome/ neck ratio <= 2; 6. Stent treatment within 0-72 hours after onset of the syndrome; 7. Stent embolization for ruptured aneurysms; 8. Informed consent signed by the patient and his family members. 

排除标准:

1. 发病前mRS≥3分; 2. 脑内血肿大于20ml; 3. 妊娠或哺乳期妇女; 4. 合并其他系统难治性疾病如肿瘤、血液病等患者。 5. 伴发严重的其他系统疾病,急性心梗死、肾功能障碍、恶性肿瘤等患者。 

Exclusion criteria:

1. mRS >= 3 prior to onset; 2. Intracerebral hematoma greater than 20ml; 3. Pregnant or lactating women; 4. Patients with other systemic refractory diseases such as tumor and hepatopathy. 5. Patients with other serious systemic diseases, acute myocardial infarction, renal dysfunction, malignant tumor, etc. 

研究实施时间:

Study execute time:

From2020-10-01To 2022-09-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

300

Group:

experimental group

Sample size:

干预措施:

支架辅助栓塞

干预措施代码:

Intervention:

Stent-assisted Coiling

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学附属仁济医院 

单位级别:

三级教学医院 

Institution
hospital:

Renji Hospital, School of Medicine, Shanghai Jiaotong University  

Level of the institution:

Tertiary Academic Hospital 

国家:

中国 

省(直辖市):

江西省 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

南昌大学附属第二医院 

单位级别:

三级教学医院 

Institution
hospital:

The Second Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary Academic Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三级教学医院 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary Academic Hospital 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

 

Country:

China 

Province:

Liaoni 

City:

 

单位(医院):

大连市中心医院 

单位级别:

三级教学医院 

Institution
hospital:

Dalian Central Hospital  

Level of the institution:

Tertiary Academic Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

金华市中心医院 

单位级别:

三级教学医院 

Institution
hospital:

Jinhua Central Hospital  

Level of the institution:

ertiary Academic Hospital 

国家:

中国 

省(直辖市):

山东省 

市(区县):

 

Country:

China 

Province:

Shangdong 

City:

 

单位(医院):

临沂市人民医院 

单位级别:

三级教学医院 

Institution
hospital:

Linyi People's Hospital  

Level of the institution:

Tertiary Academic Hospital 

国家:

中国 

省(直辖市):

山东省 

市(区县):

 

Country:

China 

Province:

Shangdong 

City:

 

单位(医院):

菏泽市立医院 

单位级别:

三级教学医院 

Institution
hospital:

Heze Municipal Hospital  

Level of the institution:

Tertiary Academic Hospital 

测量指标:

Outcomes:

指标中文名:

脑血栓事件

指标类型:

主要指标 

Outcome:

Thrombosis Event

Type:

Primary indicator 

测量时间点:

术后1月内

测量方法:

MRI影像表现

Measure time point of outcome:

One month after treatment

Measure method:

指标中文名:

脑出血事件

指标类型:

次要指标 

Outcome:

Hemorrhagic Event

Type:

Secondary indicator 

测量时间点:

1月内

测量方法:

临床症状

Measure time point of outcome:

One month after treatment

Measure method:

指标中文名:

动脉瘤复发

指标类型:

次要指标 

Outcome:

Aneurysm Recurrence

Type:

Secondary indicator 

测量时间点:

6月

测量方法:

血管造影

Measure time point of outcome:

Six month after treatment

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

无组织及液体样本

组织:

Sample Name:

No Samples

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

无随机

Randomization Procedure (please state who generates the random number sequence and by what method):

No Randomization

UTN(全球唯一识别码):

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

上海申康医院发展中心/www.shdc.org.cn

Data management Institution:

Shanghai Shenkang Hosptial Development Center/ www.shdc.org.cn

资料分析单位:

电子采集和管理系统

Data analysis Institution:

Electronic Data Capture, EDC

注册人:

Name on Registration:

 2020-08-25