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症状性颅内动脉粥样硬化性狭窄的血管内治疗的临床观察:病例注册登记研究
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注册号:

Registration number:

ChiCTR2100053823 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

症状性颅内动脉粥样硬化性狭窄的血管内治疗的临床观察:病例注册登记研究 

Public title:

Endovascular treatment for symptomatic intracranial atherosclerotic stenosis: a single center registry study 

注册题目简写:

 

English Acronym:

ETICAS 

研究课题的正式科学名称:

症状性颅内动脉粥样硬化性狭窄的血管内治疗的安全性和有效性——一项临床观察性研究 

Scientific title:

The safety and long-term outcomes of endovascular treatment in symptomatic intracranial atherosclerotic stenosis 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

杜鹃 

研究负责人:

刘新峰 

Applicant:

Du Juan 

Study leader:

Liu Xinfeng 

申请注册联系人电话:

Applicant telephone:

+86 18626451202 

研究负责人电话:

Study leader's telephone:

+86 13813835114 

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:

dujuan_200988@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

xfliu2@vip.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:

江苏省南京市中山东路305号东部战区总医院神经内科 

研究负责人通讯地址:

江苏省南京市中山东路305号东部战区总医院神经内科 

Applicant address:

305 East Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

305 East Zhongshan Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210002 

研究负责人邮政编码:

Study leader's postcode:

210002 

申请人所在单位:

东部战区总医院神经内科 

Applicant's institution:

Department of neurology, Jinling Hospital  

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:

2021NZKY-009-02 

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:

东部战区总医院临床试验伦理委员会 

Name of the ethic committee:

Ethics Committee of Jinling Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-09-08 

伦理委员会联系人:

吴琼 

Contact Name of the ethic committee:

Wu Qiong 

伦理委员会联系地址:

江苏省南京市中山东路305号东部战区总医院伦理委员会办公室 

Contact Address of the ethic committee:

305 East Zhongshan Road, Nanjing, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 025-80860225 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

东部战区总医院神经内科 

Primary sponsor:

Department of neurology, Jinling Hospital  

研究实施负责(组长)单位地址:

江苏省南京市中山东路305号东部战区总医院神经内科 

Primary sponsor's address:

305 East Zhongshan Road, Nanjing, Jiangsu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

东部战区总医院

具体地址:

江苏省南京市中山东路305号东部战区总医院神经内科

Institution
hospital:

Jinling Hospital

Address:

305 East Zhongshan Road

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

颅内动脉粥样硬化性疾病 

Target disease:

Intracranial atherosclerotic disease 

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:

探究症状性ICAS患者血管内治疗的安全性及有效性;通过多模式评估对颅内动脉粥样硬化狭窄性病变的卒中患者进行风险分层,甄别血管内治疗获益人群特征,为ICAS患者个体化治疗提供依据。 

Objectives of Study:

This study aims to explore the safety and effectiveness of endovascular treatment for symptomatic ICAS patients. We stratify the risk of stroke patients with intracranial atherosclerotic stenosis through multi-model assessment, and identify those who would benefit from endovascular treatment, in turn, provide a scientific basis for the optimizing prevention and treatment of stroke. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1)症状性颅内动脉狭窄50%-99%,影像证实的责任血管为颈内动脉颅内段、大脑中动脉、椎动脉颅内段或基底动脉; 2)接受颅内动脉血管内治疗,包括球囊血管成形术,球囊扩张式支架置入术或自膨式支架置入术; 3)症状出现至血管内治疗时间>24小时; 

Inclusion criteria

1) Imaging confirmed symptomatic intracranial artery stenosis of 50% to 99%(intracranial segment of internal carotid, middle cerebral artery, intracranial segment of vertebral artery or basilar artery); 2) Treated with endovascular treatment, including balloon angioplasty, balloon dilatation stenting, or self-dilatation stenting; 3) The time from symptom onset to endovascular treatment was > 24 hours. 

排除标准:

1)非动脉粥样硬化性狭窄,包括动脉夹层、moya-moya病或血管炎等血管疾病; 2)造影显示血管路径迂曲,介入医生判断血管内治疗器械难以到达病变部位; 3)不能配合完成随访。 

Exclusion criteria:

1) Non-atherosclerotic stenosis,such as arterial dissection, Moya-Moya disease, or vasculitis; 2) Difficulty in reaching the lesion due to the vascular tortuosity shown by the angiography; 3) Unable to complete follow-up. 

研究实施时间:

Study execute time:

From2020-01-01To 2026-12-31 

征募观察对象时间:

Recruiting time:

From2012-01-01To 2025-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

517

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

东部战区总医院 

单位级别:

三甲甲等 

Institution
hospital:

Jinling Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

卒中复发

指标类型:

主要指标 

Outcome:

recurrent stroke

Type:

Primary indicator 

测量时间点:

术后30天、90天、180天、365天,而后每年

测量方法:

电话随访或门诊/住院随访

Measure time point of outcome:

At 1, 3, 6 and 12 months after the procedure and annually thereafter.

Measure method:

Telephone follow-up or outpatient/inpatient follow-up

指标中文名:

短暂性缺血发作

指标类型:

次要指标 

Outcome:

Transient ischemic attack

Type:

Secondary indicator 

测量时间点:

术后30天、90天、180天、365天,而后每年

测量方法:

电话随访或门诊/住院随访

Measure time point of outcome:

At 1, 3, 6 and 12 months after the procedure and annually thereafter

Measure method:

Telephone follow-up or outpatient/inpatient follow-up

指标中文名:

死亡

指标类型:

次要指标 

Outcome:

Death

Type:

Secondary indicator 

测量时间点:

术后30天、90天、180天、365天,而后每年

测量方法:

电话随访或门诊/住院随访

Measure time point of outcome:

At 1, 3, 6 and 12 months after the procedure and annually thereafter

Measure method:

Telephone follow-up or outpatient/inpatient follow-up

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

观察性研究,无随机方法

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

None.

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

东部战区总医院神经内科

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Department of neurology, Jinling Hospital

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表采集数据,南京卒中登记系统进行电子采集及管理。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data were collected by case record forms, and electronic collection and management were carried out by Nanjing Stroke Registration System.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
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