Today is 2019-12-07

Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial
download

注册号:

Registration number:

ChiCTR-TRC-11001213 

最近更新日期:

Date of Last Refreshed on:

2016-03-27 

注册时间:

Date of Registration:

2011-03-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

比较双对吻挤压技术和即兴T 支架技术治疗无保护左主干末端真性分叉病变的前瞻性、多中心、随机对照研究: DKCRUSH-V trial 

Public title:

Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial 

注册题目简写:

DKCRUSH-V trial 

English Acronym:

DKCRUSH-V trial 

研究课题的正式科学名称:

比较双对吻挤压技术和即兴T 支架技术治疗无保护左主干末端真性分叉病变的前瞻性、多中心、随机对照研究: DKCRUSH-V trial 

Scientific title:

Double Kissing and Double Crush versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-center Clinical Trial 

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:

陈绍良 

研究负责人:

陈绍良 

Applicant:

Shao-Liang Chen 

Study leader:

Shao-Liang Chen 

申请注册联系人电话:

Applicant telephone:

+86 25 52208048 

研究负责人电话:

Study leader's telephone:

+86 25 52208048 

申请注册联系人传真 :

Applicant Fax:

+86 25 52208048 

研究负责人传真:

Study leader's fax:

+86 25 52208048 

申请注册联系人电子邮件:

Applicant E-mail:

chmengx@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chmengx@126.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:

南京市长乐路68号,南京医科大学附属南京第一医院 

研究负责人通讯地址:

南京市长乐路68号,南京医科大学附属南京第一医院 

Applicant address:

68 Changle Road, Nanjing, China 

Study leader's address:

68 Changle Road, Nanjing, China 

申请注册联系人邮政编码:

Applicant postcode:

210006 

研究负责人邮政编码:

Study leader's postcode:

210006 

申请人所在单位:

南京医科大学附属南京第一医院 

Applicant's institution:

Nanjing First Hospital, Nanjing Medical 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:

KY2011001 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京市第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Nanjing First Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-03-05 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

南京医科大学附属南京第一医院 

Primary sponsor:

Nanjing First Hospital, Nanjing Medical University 

研究实施负责(组长)单位地址:

南京市长乐路68号 

Primary sponsor's address:

68 Changle Road, Nanjing, 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):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省自然基金

具体地址:

江苏省南京市北京东路39号

Institution
hospital:

Natural Science Fund Projects of Jiangsu Province

Address:

39 West Beijing Road, Nanjing, China

经费或物资来源:

江苏省自然基金 

Source(s) of funding:

Natural Science Fund Projects of Jiangsu Province 

研究疾病:

冠状动脉分叉病变 

Target disease:

Unprotected distal left main coronary bifurcation lesion 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

在左主干末端真性分叉病变患者中使用雷帕霉素洗脱冠状动脉支架系统比较双对吻挤压技术(DK crush)和必要性T支架技术(Provisional T)的2年随访和冠状动脉造影结果的临床随机研究。 

Objectives of Study:

To evaluate the safety and effectiveness of the DK crush stenting technique for the treatment of subjects with unprotected distal left main true bifurcation lesions. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 稳定性心绞痛、不稳定性心绞痛和从胸痛发作到诊断为急性心肌梗死超过24小时的患者; 2. 左主干末端真性分叉病变(Medina 分型为1,1,1或 0,1,1型)有/无开口/体部病变; 3. 前降支或回旋支分支血管病变最多需要两根支架以完全覆盖病变; 4. 左主干末端真性分叉病变合并有前降支或回旋支或右冠状动脉慢性完全闭塞病变成功再通后; 5. 适合经皮冠状动脉介入治疗; 6. 前降支/左主干和回旋支目测直径狭窄≥50%; 7. 签署书面知情同意书。 

Inclusion criteria

1. Documented Stable/unstable angina or AMI>24-hour from the onset of chest pain to admission; 2. LMb (Medina 0, 1, 1/1, 1, 1) with/without ostial/shaft lesions; 3. Downstrem lesions in LAD or LCX could be covered by two stents; 4. LMb with CTO lesion in LAD, or LCX or RCA after recanalization; 5. Patients eligible to be treated by PCI; 6. Diameter stenosis in LAD/LMT and LCX >=50% by visual estimation; 7. Signed informed consent. 

排除标准:

1. 从胸痛发作到诊断为急性心肌梗死小于24小时的受试者; 2. 受试者预期寿命<1年; 3. 受试者对方案要求的伴随药物过敏; 4. 受试者不能耐受双重抗血小板治疗; 5. 受试者对雷帕霉素过敏; 6. 前降支或回旋支或右冠状动脉任何一个慢性完全闭塞病变未能成功再通; 7. 孕妇; 8. 严重钙化需要旋磨治疗。 

Exclusion criteria:

1. STEMI <24-hour from the onset of chest pain to admission; 2. Expected survival <1 year; 3. Allergy to indexed medications; 4. Intolerable to dual antiplatelet therapy; 5. Allergy to sirolimus; 6. CTO lesion in either LAD,or LCX or RCA not recanalized; 7. Women in pregnant; 8. Severe calcification needing rotational athrectomy. 

研究实施时间:

Study execute time:

From2011-12-30To 2017-02-28 

干预措施:

Interventions:

组别:

A组

样本量:

242

Group:

Group A

Sample size:

干预措施:

使用Provisional 技术在左主干分叉部位置入雷帕霉素药物涂层支架

干预措施代码:

Intervention:

Using provision technique,stents in MV.If additional stent being required in side branch.

Intervention code:

组别:

B组

样本量:

242

Group:

Group B

Sample size:

干预措施:

用DK crush 技术在左主干分叉部位置入雷帕霉素药物涂层支架

干预措施代码:

Intervention:

Using DK crush technique Implants stents in MV and SB

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):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京医科大学附属南京第一医院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing First Hospital, Nanjing Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国人民解放军沈阳军区总医院 

单位级别:

三甲医院 

Institution
hospital:

The General Hospital of Shenyang Military of PLA  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建医科大学附属协和医院 

单位级别:

三甲医院 

Institution
hospital:

Fujian Medical University Union Hospital, China  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省郑州医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Zhengzhou Medical University, China  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津武警医学院附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Chinese People's Armed Police Force Logistics College, China  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

陕西第四军医大学第一附属医院/西京医院 

单位级别:

三甲医院 

Institution
hospital:

Xijing Hospital, The Fourth Military Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital, Tongji Medical College of HUST  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广州 

市(区县):

 

Country:

China 

Province:

Guangzhou 

City:

 

单位(医院):

广州市红十字会医院 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Red Cross Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医学院附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Affiliated Hospital of Xuzhou Medical Collage  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Henan Province People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

印度尼西亚 

省(直辖市):

Indonesia 

市(区县):

 

Country:

Indonesia 

Province:

Indonesia 

City:

 

单位(医院):

University of Indonesia Medical School, Indonesia  

单位级别:

三级医院 

Institution
hospital:

University of Indonesia Medical School, Indonesia  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建厦门大学附属中山医院 

单位级别:

三甲医院 

Institution
hospital:

Xiamen Cardiovascular Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第一中心医院医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin First Central Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

大庆油田总医院 

单位级别:

三甲医院 

Institution
hospital:

Daqing Oil Field general hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

江西省人民医院 

单位级别:

三甲医院 

Institution
hospital:

The Jiangxi Provincial People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海瑞金医院 

单位级别:

三甲医院 

Institution
hospital:

Ruijin Hospital, Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海第十人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Tenth People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京朝阳医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Chao-yang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

许昌市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Xuchang Central Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁省人民医院 

单位级别:

三甲医院 

Institution
hospital:

The People's Hospital of Liaoning Province  

Level of the institution:

Tertiary A hospital 

国家:

泰国 

省(直辖市):

曼谷 

市(区县):

 

Country:

Thailand 

Province:

Bangkok 

City:

 

单位(医院):

Bangkok General Hospital, Vajira Medical University 

单位级别:

三级医院 

Institution
hospital:

Bangkok General Hospital, Vajira Medical University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南大学淮河医院 

单位级别:

三甲医院 

Institution
hospital:

Henan University Huaihe Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东医科大学山东省立医院 

单位级别:

三甲医院 

Institution
hospital:

Shandong Provincial Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉亚洲心脏病医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan Asia Heart Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Gansu Provincial Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广西 

市(区县):

 

Country:

China 

Province:

Guangxi 

City:

 

单位(医院):

广西壮族自治区人民医院 

单位级别:

三甲医院 

Institution
hospital:

The People's Hospital of Guangxi Zhuang Autonomous Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省宁波市第一医院 

单位级别:

三甲医院 

Institution
hospital:

Ningbo First Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

PCI术后12个月靶病变失败率

指标类型:

主要指标 

Outcome:

Target lesion failure (TLF) rate at 12 months post-index procedure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

管腔直径净获得

指标类型:

次要指标 

Outcome:

Net gain of lumen diameter

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

确定的或可能的支架内血栓

指标类型:

次要指标 

Outcome:

Definite and probable stent thrombosis.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支架内再狭窄

指标类型:

次要指标 

Outcome:

In-stent restenosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支架置入术后第1年和第2年的联合终点

指标类型:

次要指标 

Outcome:

Cardiac death, Target-vessel myocardial infarction (TV-MI), or Target lesion revascularization (TLR).

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中风

指标类型:

附加指标 

Outcome:

Stroke

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中器材消耗

指标类型:

附加指标 

Outcome:

Devices consumed during indexed procedure

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间

指标类型:

附加指标 

Outcome:

Procedural time

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

对比剂量

指标类型:

附加指标 

Outcome:

Contrast volume

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

靶血管支配区域心肌梗死

指标类型:

次要指标 

Outcome:

Target-vessel myocardial infarction (TV-MI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

计算机软件

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

computer generation

盲法:

数据分析委员会是由不知道治疗分组信息的独立的委员会进行临床研究终点分析

Blinding:

Data analysis of the committee: Blinding

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

南京医科大学附属南京第一医院

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

PCI Research, Cardiac Cath. Lab., Nanjing First Hospital of Nanjing Medical University

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:

南京医科大学临床流行病学教研室

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

The Department of Epidemiology & Statistics, School of Public Health,Nanjing Medical University,

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-03-10
return list