ChiCTR2300071356 版本V1.0 版本创建时间2023/05/12 10:52:48 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：

 ChiCTR2300071356 

最近更新日期：

Date of Last Refreshed on：

 2023-05-12 10:52:27 

注册时间：

Date of Registration：

 2023-05-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

拘禁球囊近段优化技术在冠脉真性分叉病变中的多中心RCT研究

Public title：

Multicenter Randomized Controlled Trial of Jailed Balloon Proximal Optimization Techniquein in True Bifurcation of Coronary Artery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

拘禁球囊近段优化技术在冠脉真性分叉病变中的多中心RCT研究

Scientific title：

Multicenter Randomized Controlled Trial of Jailed Balloon Proximal Optimization Techniquein in True Bifurcation of Coronary Artery

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：

高春城 

研究负责人：

郭万刚 

Applicant：

gaochuncheng 

Study leader：

guowangang 

申请注册联系人电话：

Applicant telephone：

 +86 177 6658 4998

研究负责人电话：

Study leader's
telephone：

+86 186 2958 1753

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：

 83459303@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 wg_guoxn@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：

中国陕西省西安市空军军医大学唐都医院心内科

研究负责人通讯地址：

中国陕西省西安市空军军医大学唐都医院心内科

Applicant address：

Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China

Study leader's address：

Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China

申请注册联系人邮政编码：

Applicant postcode：

 710038

研究负责人邮政编码：

Study leader's postcode：

 710038

申请人所在单位：

中国陕西省西安市空军军医大学唐都医院心内科

Applicant's institution：

Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China

研究负责人所在单位：

中国陕西省西安市空军军医大学唐都医院心内科

Affiliation of the Leader：

Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China

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：

 第202304-18号

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：

中国人民解放军第四军医大学唐都医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-04-13 00:00:00

伦理委员会联系人：

李诗草

Contact Name of the ethic committee：

lishicao

伦理委员会联系地址：

中国陕西省西安市空军军医大学唐都医院伦理委员会

Contact Address of the ethic committee：

Ethics Committee of Tangdu Hospital, Air Force Medical University, Xi’an, Shaanxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 29 8471 7761

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tangduec@126.com

研究实施负责（组长）单位：

空军军医大学唐都医院心内科

Primary sponsor：

Department of Cardiology, Tangdu Hospital, Air Force Medical University

研究实施负责（组长）单位地址：

中国陕西省西安市灞桥区新寺路空军军医大学唐都医院

Primary sponsor's address：

Tangdu Hospital, Air Force Military Medical University, Xinsi Road, Baqiao District, Xi 'an, Shaanxi, 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)：

陕西

市(区县)：

西安

Country：

china

Province：

Shaanxi

City：

Xi’an

单位(医院)：

唐都医院

具体地址：

中国陕西省西安市灞桥区新寺路空军军医大学唐都医院

Institution
hospital：

Tangdu Hospital

Address：

Tangdu Hospital, Air Force Military Medical University, Xinsi Road, Baqiao District, Xi 'an, Shaanxi, China

经费或物资来源：

空军军医大学科研学术处

Source(s) of funding：

Research and Academic Division, Air Force Medical University

研究疾病：

冠脉真性分叉病变  

Target disease：

True Bifurcation of Coronary Artery

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探讨JB-POT在介入治疗真性分叉病变时的即刻效果；探讨JB-POT对冠脉真性分叉病变患者远期预后的影响。  

Objectives of Study：

To investigate the immediate effect of JB-POT in the interventional treatment of true bifurcation lesions and its influence on the long-term prognosis of patients with true bifurcation lesions.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄18-90岁的冠心病患者； （2）冠脉影像学提示非左主干真性分叉病变（Medina 1,1,1或0,1,1或1,0,1），主支直径狭窄程度≥ 70%，主支直径≥2.5mm，TIMI血流 ≥ 1 级，主侧支角度不超过70°，侧支直径狭窄程度<90%，侧支病变长度<10mm; （3）经术者综合评价后该分叉病变需要边支保护，拟采用必要时支架术（provisional stenting，PS）的患者; （4）靶血管既往无PCI及冠状动脉旁路移植术（CABG）史； （5）未参与其他研究。

Inclusion criteria

(1) patients with coronary heart disease aged 18-90 years; (2) Coronary imaging suggested non-left main true bifurcation lesions (Medina 1,1,1 or 0,1,1 or 1,0,1), the stenosis degree of main branch diameter ≥ 70%, main branch diameter ≥2.5mm, TIMI blood flow ≥ 1, the Angle of main branch was not more than 70°, the stenosis degree of lateral branch diameter<90%, length of collateral lesions<10mm; (3) Patients whose bifurcated lesions need side branch protection after comprehensive evaluation by the surgeon, and who plan to use stenting if necessary; (4) No previous history of PCI and coronary artery bypass grafting in the target vessel; (5) Did not participate in other studies.

排除标准：

（1）经术者判定符合冠脉搭桥的患者； （2）左心室射血分数（LVEF）<40%或明显心衰临床表现； （3）有严重钙化、弯曲的病变； （4）对阿司匹林、氯吡格雷或替格瑞洛过敏者； （5）有非一过性肝功能障碍、凝血功能障碍或高出血风险的患者； （6）1年内拟接受非心脏手术，需要中断抗血小板聚集药物使用的患者； （7）合并其他疾病，预期寿命少于3个月者； （8）妊娠期患者； （9）严重精神障碍性疾病无法配合手术或后期随访的患者。

Exclusion criteria：

(1) Patients determined by the surgeon to be eligible for coronary artery bypass grafting; (2) left ventricular ejection fraction (LVEF) <40% or obvious clinical manifestations of heart failure; (3) severe calcification and curvature of the lesion; (4) Allergic to aspirin, clopidogrel or ticagrelor; (5) Patients with non-transient liver dysfunction, coagulopathy or high blood risk; (6) Patients who plan to receive non-cardiac surgery within 1 year and need to discontinue the use of antiplatelet aggregation drugs; (7) Patients with other diseases and life expectancy less than 3 months; (8) patients during pregnancy; (9) Patients with serious mental disorders that can not cooperate with surgery or follow-up.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-12 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：

JB-POT组

样本量：

 55

Group：

JB-POT group

Sample size：

干预措施：

按照JB-POT技术的操作步骤对患者进行治疗：a.两根导丝分别进入主支和分支；b.若冠脉造影发现分叉病变轻度钙化，则行IVUS评估，若无“排除标准（2）”则拘禁球囊进入边支（边支球囊近端超出主支支架近端约2 mm，球囊远段保留在边支内，直径1.5-2.0mm）；c.用半顺应性球囊预扩张主支病变，评估边支；d.按照主支血管远段参考直径选择支架，在拘禁球囊状态下12~14 atm释放支架，评估边支；e.采用于主支远段直径匹配NC Traveler球囊采用12-16 atm后扩张主支支架远段，采用与主支近段直径匹配NC Traveler球囊采用12-16 atm后扩张多边形区域（POT技术）和主支支架近段，评估边支；f.bde步骤后均评估边支血流，如果TIMI血流分级下降1级以上，将拘禁球囊扩张8 atm恢复血流，若果血流无影响直接进行下一步；g.撤出拘禁球囊和拘禁导丝，主支近段直径匹配NC Traveler球囊采用12-16 atm后扩主支支架近段（NC球囊远端在边支起始近侧2 mm）；h.术毕，记录手术时长、累计射线计量和造影剂使用剂量。

干预措施代码：

Intervention：

Patients were treated according to the procedure of JB-POT technique: a. Two guide wires were inserted into the main branch and branch respectively; b. If coronary angiography found mild calcification of bifurcated lesions, IVUS evaluation was performed; if there was no "exclusion criteria (2)", the balloon was confined into the side branch (the proximal end of the side branch balloon was about 2 mm beyond the proximal end of the main branch stent, and the distal part of the balloon was retained in the side branch, with a diameter of 1.5-2.0mm). c. Predilation of main rami with semi-compliant balloon was used to evaluate side rami; d. Stents were selected according to the reference diameter of the distal segment of the main branch. The stents were released at 12-14 atm under the condition of incarcerated balloon, and the side branches were evaluated. e. The NC Traveler balloon was used to match the distal diameter of the main branch. The NC Traveler balloon was used to expand the distal portion of the main branch after 12-16 atm, and the NC Traveler balloon was used to expand the polygon area after 12-16 atm (POT technology) and the proximal segment of the main branch to evaluate the side branches. After the steps of f.bde, the side branch blood flow was evaluated. If the blood grade of TIMI decreased by more than 1 level, the detention balloon was expanded by 8 atm to restore blood flow. If the blood flow was not affected, the next step was directly carried out. g. The imprisoning balloon and the imprisoning guide wire were withdrawn, and the diameter of the proximal segment of the main branch was matched with the NC Traveler balloon using 12-16 atm to expand the proximal segment of the main branch (the distal end of the NC balloon was 2 mm near the beginning of the side branch). h. After the operation, the duration of operation, cumulative radiometric measurement and the dose of contrast agent were recorded.

Intervention code：

组别：

传统术式组

样本量：

 55

Group：

JWT+POT group

Sample size：

干预措施：

传统术式组：a.两根导丝分别进入主支和分支；b.若冠脉造影发现分叉病变轻度钙化，则行IVUS评估，若无“排除标准（2）”，用半顺应性球囊预扩张主支病变，评估边支;c.按照主支血管远段参考直径选择支架，在拘禁导丝状态下12~14 atm释放支架，评估边支；d.若边支血流无受损，撤出支架球囊，回撤主支导丝掏支架网眼入边支，回撤边支导丝出支架近端再穿支架支主支远端（交换导丝）；e.经主支导丝送入与主支远段直径匹配NC Traveler球囊采用10-16 atm后扩张主支支架，撤出球囊，评估边支； f.经主支导丝送入与主支近段直径匹配NC Traveler球囊采用10-16 atm后扩张主支支架（POT技术），撤出球囊，评估边支；g.bcef步骤后均评估边支，TIMI血流分级下降1级以上，经边支导丝送入直径相适应的NC球囊入边支口部10-12atm扩张，并与主支后扩球囊完成对吻扩张，支架近段POT，再复查造影，结合造影结果，评估边支，由术者根据EBC15次专家共识建议决定是否进一步边支架植入治疗；h.术毕，记录手术时长、累计射线计量和造影剂使用剂量。

干预措施代码：

Intervention：

In the traditional operation group, a. Two guide wires enter the main branch and branch respectively; b. If coronary angiography revealed mild calcification of bifurcated lesions, IVUS evaluation was performed. If there was no "exclusion criteria (2)", the main branch lesion was pre-dilated with a semi-compliant balloon to evaluate the side branch. c. The stent was selected according to the reference diameter of the distal segment of the main vessel, and the stent was released at 12-14 atm under the state of incarcerated guide wire to evaluate the side branches; d. If the blood flow in the side branch is not damaged, the balloon of the stent is withdrawn, and the guide wire of the main branch is pulled out of the stent mesh into the side branch. The guide wire of the side branch is pulled out of the proximal end of the stent and then through the distal end of the main branch of the stent (exchange guide wire). e. Send the NC Traveler balloon matching the diameter of the distal segment of the main branch through the main branch guide wire and use 10-16 atm to expand the main branch stent, withdraw the balloon, and evaluate the side branch; f. The NC Traveler balloon matching the diameter of the near segment of the main branch was sent through the main branch guide wire, and the main branch stent was expanded by 10-16 atm (POT technique), and the balloon was withdrawn to evaluate the side branch. After the procedure of g.bcef, side branches were evaluated, and the blood grade of TIMI decreased by more than 1 level. The NC balloon with appropriate diameter was sent through the side branch guide wire into the mouth of the side branch for expansion at 10-12 ATM, and then the expansion was completed with the posterior expansion balloon of the main branch. The surgeon decides whether to further stent implantation according to 15 EBCexpert consensus recommendations; h. After the operation, the duration of operation, cumulative radiometric measurement and the dose of contrast agent were recorded.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 西安 

Country：

China

Province：

Shaanxi

City：

Xi’an

单位(医院)：

 唐都医院 

单位级别：

 三甲 

Institution
hospital：

Tangdu Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China

Province：

Shaanxi

City：

单位(医院)：

 渭南市第二医院 

单位级别：

 二级甲等 

Institution
hospital：

Weinan Second Hospital

Level of the institution：

Secondary A

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China

Province：

Shaanxi

City：

单位(医院)：

 西安宝石花长庆医院 

单位级别：

 二甲 

Institution
hospital：

Xi'an Baoshi Flower Changqing Hospital

Level of the institution：

Secondary A

测量指标：

Outcomes：

指标中文名：

PCI术中边支闭塞发生率

指标类型：

主要指标

Outcome：

Incidence of branch occlusion during PCI

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

分支需要重进导丝的发生率

指标类型：

次要指标

Outcome：

The incidence of branch reentry guide wire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

重进分支导丝的成功率

指标类型：

次要指标

Outcome：

Success rate of reentering branch guide wire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术毕分支及主支 TIMI 血流

指标类型：

次要指标

Outcome：

TIMI blood flow in main branches and branches after operation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

围术期及术后12个月的主要不良心血管事件的发生率

指标类型：

次要指标

Outcome：

The incidence of major adverse cardiovascular events during perioperative period and 12 months after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

造影剂使用剂量

指标类型：

次要指标

Outcome：

Dose of contrast agent used

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

累及射线计量

指标类型：

次要指标

Outcome：

Gamma ray measurement is involved

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术时长

指标类型：

次要指标

Outcome：

Operation duration

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：

标本中文名：

不涉及采集人体标本

组织：

Sample Name：

There is no human specimen collection involved

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 90 岁 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）：

由唐都医院医院的独立统计学家从随机数字表中的任意一行任意一列开始，依次读取110个2位随机数，要求单数和双数的随机数个数相等，若不等，从新提取直至相等，依次录于1-110个事先拟定的研究对象的编号下；然后将全部随机数分为单双数两组，单数55个为A组，双数55个为B组；规定A组使用JB-POT术式，B组使用JW-POT常规术式。

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

The independent statisticians of Tangdu Hospital read 110 2-digit random numbers successively starting from any row or any column in the random number table. The numbers of singular and even numbers are required to be equal. If they are not equal, they are extracted again until they are equal, and recorded in sequence under the numbers of 1-110 pre-formulated research objects; Then all the random numbers were divided into two groups: single and even numbers, 55 singular numbers were group A, and

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

不共享原始数据

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

Raw data is not shared

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：

病例记录表主要由6个部分组成，第一部分为受试者的基本信息，包括姓名、性别、出生年月、联系方式等等；第二部分受试者的纳入标准；第三部分为受试者的排除标准；第四部分为受试者的一些基线资料信息，包括既往病史如高血压、糖尿病、高血脂、心梗、支架、冠脉搭桥等等；第五部分为受试者术中病变的描述、接受治疗处置的情况，如分叉病变部位及分叉角度，术前主支直径、狭窄程度、病变长度及TIMI血流，术中主要终点和次要终点事件发生的情况，以及处置的情况等等；最后一部分为受试者随访内容的记录，包括主要不良心血管事件发生情况，以及进行疾病复查的时间地点和化验检查结果等等。

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

The case record form is mainly composed of six parts. The first part is the basic information of the subject, including name, gender, date of birth, contact information and so on. Part II Inclusion criteria of subjects; The third part is the exclusion criteria of subjects; The fourth part is some baseline information of the subjects, including previous medical history such as hypertension, diabetes, hyperlipidemia, myocardial infarction, stents, coronary artery bypass, etc. The fifth part is the description of intraoperative lesions and treatment treatment of subjects, such as site and Angle of bifurcation lesions, preoperative main branch diameter, degree of stenosis, length of lesions and TIMI blood flow, occurrence of intraoperative primary and secondary end points, and treatment, etc. The last part is a record of the subjects' follow-up, including the occurrence of major adverse cardiovascular events, the time and place of disease review and the results of laboratory tests.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

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Name of Registration：

  2023-05-12 10:52:27