ChiCTR2500104676 版本V1.0 版本创建时间2025/06/20 15:50:10 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：

ChiCTR2500104676 

最近更新日期：

Date of Last Refreshed on：

2025-06-20 15:50:02 

注册时间：

Date of Registration：

2025-06-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

多中心、前瞻性全降解冠脉药物洗脱支架系统（商品名：阿迈特AMSorb TM）临床注册试验

Public title：

Multicenter and prospective clinical trial of bioresorbable coronary drug-eluting stent system (Trade name: AMSorb TM)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多中心、前瞻性全降解冠脉药物洗脱支架系统（商品名：阿迈特AMSorb TM）临床注册试验

Scientific title：

Multicenter and prospective clinical trial of bioresorbable coronary drug-eluting stent system (Trade name: AMSorb TM)

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：

陈思琪 

研究负责人：

霍勇 

Applicant：

Chen Siqi 

Study leader：

Huo Yong 

申请注册联系人电话：

Applicant telephone：

+86 133 7160 3730

研究负责人电话：

Study leader's telephone：

+86 10 8357 5205

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：

sqchen@ametcorp.com

研究负责人电子邮件：

Study leader's E-mail：

huoyong@263.net.cn

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：

北京市大兴区中关村科技园区大兴生物医药基地永旺西路26号院11号楼

研究负责人通讯地址：

北京市西城区西什库大街8号

Applicant address：

26 Yongwang West Rd, Building 11, Zhong-Guan-Cun Medical Device Industrial Park, Daxing District, Beijing 102609, China

Study leader's address：

No. 8 Xishiku Street, Xicheng District, Beijing

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：

北京阿迈特医疗器械有限公司

Applicant's institution：

Beijing Advanced Medical Technologies, Ltd. Inc.

研究负责人所在单位：

北京大学第一医院

Affiliation of the Leader：

Peking University First Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2016) 器械注册第(17)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：

北京大学第一医院国家药物临床试验伦理委员会

Name of the ethic committee：

National Ethics Committee for Drug Clinical Trials, Peking University First Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2016-11-23 00:00:00

伦理委员会联系人：

蒋捷

Contact Name of the ethic committee：

Jiang Jie

伦理委员会联系地址：

北京市西城区西什库大街8号

Contact Address of the ethic committee：

No. 8 Xishiku Street, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6611 9025

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：

北京大学第一医院

Primary sponsor：

Peking University First Hospital

研究实施负责（组长）单位地址：

北京市西城区西什库大街8号

Primary sponsor's address：

No. 8 Xishiku Street, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京阿迈特医疗器械有限公司

具体地址：

北京市大兴区中关村科技园区大兴生物医药基地永旺西路26号院11号楼

Institution
hospital：

Beijing Advanced Medical Technologies, Ltd. Inc.

Address：

26 Yongwang West Rd, Building 11, Zhong-Guan-Cun Medical Device Industrial Park, Daxing District, Beijing 102609, China

经费或物资来源：

北京阿迈特医疗器械有限公司

Source(s) of funding：

Beijing Advanced Medical Technologies, Ltd. Inc.

Target disease：

Coronary artery stenosis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本临床注册试验是为完成国家药品监督管理局对试验器械上市注册进行的研究。包括试验可行性部分和确证性部分。 第一部分：根据国家食品药品监督管理总局医疗器械技术审评中心2019年3月1日发布的《生物可吸收冠状动脉药物洗脱支架临床试验指导原则》，所有冠状动脉药物洗脱支架临床注册试验均应进行不少于30例的可行性试验，故本试验严格遵守此法规，设定总例数为30例的可行性试验。 第二部分：通过多中心、随机对照临床试验来验证本研究器械的安全性和有效性，以支持申报国家药品监督管理局（NMPA）的产品注册批准。本临床试验中随机对照试验以海利欧斯（HELIOS）支架系统为对照以支架节段内（In-segment）晚期管腔丢失（Late Luminal Loss, LLL）为主要终点。单臂临床试验以靶病变失败率（Target Lesion Failure, TLF）为主要终点共同评价阿迈特AMSorbTM全降解冠脉药物洗脱支架系统（商品名：阿迈特AMSorbTM）在冠脉血运重建术中的安全性和有效性。  

Objectives of Study：

This clinical registration trial is a study conducted by the National Medical Products Administration (NMPA) to complete the market registration of experimental devices. Including FIM and RCT. FIM Part: According to the "Guidelines for Clinical Trials of Bioabsorbable Coronary drug-eluting Stents" issued by the center for Medical Device Evaluation.NMPA on March 1, 2019, all clinical registration trials of coronary drug-eluting stents should conduct FIM with no less than 30 cases. Therefore, this trial strictly complies with this regulation and sets the total number of FIM as 30 cases. RCT and single arm Part: Verify the safety and efficacy of the investigational device through multicenter, randomized controlled clinical trials to support the application for product registration approval by the NMPA. In this clinical trial, a randomized controlled trial was conducted using the HELIOS stent system as the control, with in segment late luminal loss (LLL) as the primary endpoint. The single arm clinical trial evaluated the safety and efficacy of the AMSorbTM fully degradable coronary drug-eluting stent system (trade name: AMSorbTM) in coronary revascularization surgery with target lesion failure (TLF) as the primary endpoint.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

FIM： 一般入选标准： 1）年满18岁～79岁的男性或非妊娠期女性； 2）适合接受择期PCI； 3）受试者必须为CABG手术的合格候选人； 4）受试者同意在未达到本试验终点前不参与其他临床试验； 5）受试者/法定授权代表/监护人了解试验目的和程序并自愿签署知情同意书，愿意进行有创影像学随访的患者。 RCT和单臂同FIM的一般入选标准一致。 FIM的血管造影入选标准： 1）单一靶血管上的单个靶病变； 2）靶病变必须位于自体冠脉中，目测或定量评估的%DS≥50%，且＜100%且血流TIMI≥1级； 3）靶病变在线QCA测得的Dmax≥3.0mm且＜3.25mm或目测所得的RVD≥3.0mm且≤3.25mm（建议采用在线QCA测量）； 4）靶病变目测长度或在线QCA测得长度必须≤19mm。 RCT和单臂的血管造影入选标准： 1）一个或者两个原发靶病变: a.如受试者只有一个靶病变，可对其另一个非靶病变进行治疗，但此非靶病变必须位于不同的心外膜冠脉血管上。在对受试者进行随机分组前，且必须先对该非靶病变成功地完成治疗。 b.如受试者患有两个靶病变，那么这两个靶病变必须位于不同的心外膜冠脉血管上，且必须同时符合血管造影的入排标准。 c.心外膜血管包括左前降支动脉（LAD）及其分支，左回旋支动脉（LCX）及其分支，及右冠状动脉（RCA）及其分支。因此，举例来说，受试者不得同时有两个位于LAD及其分支的病变需要治疗。 注：除急救支架以外，每位受试者无论是一处靶病变还是二处靶病变，每处靶病变只允许植入一枚支架，且每位受试者只能植入同一种支架。 2）靶病变直径狭窄程度目测≥70%（或者≥50%同时在该范围有心肌缺血的临床证据），且＜100%，TIMI血流≥1级； 3）靶病变长度≤28mm（目测）；靶病变血管直径在2.5mm至4.0mm之间；每一靶病变可被一个支架完全覆盖。

Inclusion criteria

FIM: General selection criteria: 1)Age between 18 and 79 years, male or non pregnant female. 2)Suitable for accepting elective PCI; 3) The subjects must be qualified candidates for CABG surgery; 4) The subjects agree not to participate in other clinical trials before reaching the endpoint of this trial; 5) Subjects/legally authorized representatives/guardians who understand the purpose and procedures of the trial and voluntarily sign informed consent forms, and are willing to undergo invasive imaging follow-up. The general selection criteria of RCT and single arm are the same as the FIM . Angiography inclusion criteria of FIM: 1) Single target lesion on a single target vessel; 2) The target lesion must be located in the autologous coronary artery, with a visual or quantitative evaluation of% DS >= 50%,<100%, and a blood flow TIMI >= 1 grade; 3) The Dmax measured by online QCA of the target lesion is >=3.0mm and < 3.25mm, or the RVD measured by visual inspection is>= 3.0mm and <= 3.25mm (it is recommended to use online QCA measurement); 4) The visual length of the target lesion or the length measured by online QCA must be <= 19mm. Angiography inclusion criteria of RCT and Single arm: 1) One or two primary target lesions: a. If the subject has only one target lesion, treatment can be given to another non target lesion, but this non target lesion must be located on a different epicardial coronary artery. Before randomly grouping the subjects, it is necessary to successfully complete the treatment for the non target lesion. b. If the subject has two target lesions, these two target lesions must be located on different epicardial coronary vessels and must meet the inclusion and exclusion criteria of angiography at the same time. c. The epicardial vessels include the left anterior descending artery (LAD) and its branches, the left circumflex artery (LCX) and its branches, and the right coronary artery (RCA) and its branches. Therefore, for example, subjects must not have two lesions located in the LAD and its branches that require treatment at the same time. Note: Except for emergency stents, each subject is only allowed to implant one stent for each target lesion, whether it is one or two target lesions, and each subject can only implant the same type of stent. 2) The visual stenosis degree of the target lesion diameter is >=70% (or ≥ 50% with clinical evidence of myocardial ischemia in this range), and<100%, with TIMI blood flow >= grade 1; 3) Target lesion length <= 28mm (visual inspection); The target lesion vessel diameter is between 2.5mm and 4.0mm; Each target lesion can be completely covered by a stent.

排除标准：

FIM： 一般排除标准： 1）心源性休克； 2）在手术前7天内曾有过急性心肌梗死 (AMI) 并且手术时肌酸激酶同工酶 (CK-MB) 仍未恢复到正常值范围(ULN)； 3）术前365天内曾接受靶血管PCI治疗，或术前30天内接受过非靶血管PCI治疗；预计需要对靶血管进行分期PCI治疗； 4）严重心力衰竭（NYHAIII级及以上）或左室射血分数（LVEF）＜35%（超声或左室造影）； 5）术前肾功能损害：血清肌酐＞176μmol/L；或正在接受血液透析治疗； 6）有出血倾向、活动性消化道溃疡、脑出血史或蛛网膜下腔出血史、半年内缺血性脑卒中史、抗血小板制剂和抗凝剂治疗禁忌证者、无法进行抗栓治疗的患者； 7）对阿司匹林、氯吡格雷、肝素、造影剂、多聚乳酸聚合物及雷帕霉素过敏者； 8）入选前参加过其他药物或医疗器械临床试验而未达到主要研究终点时限者； 9）研究者判断患者依从性差，无法按照要求完成临床试验； 10）实质器官移植患者，或准备接受器官移植患者； 11）有不稳定性心律失常，如高危室性早搏、室性心动过速； 12）由于肿瘤需要接受化疗； 13）有免疫抑制性、自身免疫系统疾病，计划或正在接受免疫抑制治疗； 14）计划或正在接受长期抗凝治疗，如肝素、华法林等； 15）半年内有择期外科手术，需要停用阿司匹林、氯吡格雷的患者； 16）血常规检测提示血小板计数低于100×109/L，或大于700×109/L，白细胞低于3×109/L； 17）患者有弥漫性外周性血管疾病，无法使用6F导管。 血管造影排除标准： 1）靶病变位于左主干； 2）右冠状动脉（RCA）位于主动脉开口处的靶病变（位于RCA的主动脉接合处3mm范围内）； 3）靶病变位于左前降支动脉（LAD）或左回旋支动脉（LCX）起点3mm范围内； 4）靶病变涉及到分叉且存在以下特点： A．侧支直径≥2mm； B．直径狭窄≥50%； C．侧支需要使用保护导丝或侧支需要预扩张。 5）靶病变近端或病变内的解剖结构会妨碍阿迈特可吸收支架的输送，包括： A．靶病变近端或病变内的极度反弓（≥90°）； B．靶病变近端或病变内过度弯曲（≥两个45°角）； C．靶病变近端或内部的中度或重度钙化。 6）处理靶病变涉及心肌桥； 7）血管造影图像显示靶血管中含有血栓； 8）在进行起点手术前，靶血管曾接受过支架治疗而致阿迈特可吸收支架将需要通过已植入支架才能到达靶病变； 9）靶血管曾接受过支架治疗，且靶病变位于曾接受过治疗的病变的近端5mm以内； 10）预扩张球囊无法在靶病变部位完全扩张。完全扩张基于以下标准： A．残余病变直径狭窄率（%DS）必须≤40%（目测），强烈建议≤20%（目测）； B．血流达到TIMI3级（目测）； C．无血管造影并发症（例如远端栓塞、侧支封闭）； D．无夹层NHLBI级D-F型； E．无持续胸疼（＞5分钟）且无持续＞5分钟的ST段压低或抬高。 RCT和单臂： RCT和单臂的一般排除标准： 1）1周内的任何急性心肌梗死或心梗后CK-MB没有恢复到正常； 2）1年内靶血管植入过任何支架，有计划半年内进行再次介入治疗的患者； 3）严重心力衰竭（NYHA III级及以上）或左室射血分数＜30%（超声或左室造影）； 4）术前肾功能损害：血清肌酐＞176μmol/L；或正在接受血液透析治疗； 5）有出血倾向、活动性消化道溃疡、脑出血史或蛛网膜下腔出血史、半年内缺血性脑卒中史、抗血小板制剂和抗凝剂治疗禁忌证者、无法进行抗栓治疗的患者； 6）对阿司匹林、氯吡格雷、肝素、造影剂、多聚乳酸聚合物及雷帕霉素过敏者； 7）入选前参加过其他药物或医疗器械临床试验而未达到主要研究终点时限者； 8）研究者判断患者依从性差，无法按照要求完成临床试验； 9）实质器官移植患者，或准备接受器官移植患者； 10）有不稳定性心律失常，如高危室性早搏、室性心动过速； 11）由于肿瘤需要接受化疗； 12）有免疫抑制性、自身免疫系统疾病，计划或正在接受免疫抑制治疗； 13）计划或正在接受长期抗凝治疗，如肝素、华法林等； 14）半年内有择期外科手术，需要停用阿司匹林、氯吡格雷的患者； 15）血常规检测提示血小板计数低于100×109/L，或大于700×109/L，白细胞低于3×109/L； 16）患者有弥漫性外周性血管疾病，无法使用6F导管。 RCT和单臂的血管造影排除标准与FIM一致。

Exclusion criteria：

FIM: General exclusion criteria: 1) Cardiogenic shock; 2) Within 7 days prior to surgery, there was an acute myocardial infarction (AMI) and creatine kinase isoenzyme (CK-MB) had not yet returned to the normal range (ULN) at the time of surgery; 3) Received target vessel PCI treatment within 365 days prior to surgery, or received non target vessel PCI treatment within 30 days prior to surgery; It is expected that staged PCI treatment will be required for the target vessel; 4) Severe heart failure (NYHA III or above) or left ventricular ejection fraction (LVEF)<35% (ultrasound or left ventricular angiography); 5) Preoperative renal dysfunction: serum creatinine>176 μ mol/L; or currently undergoing hemodialysis treatment; 6) Patients with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, history of ischemic stroke within six months, contraindications to antiplatelet and anticoagulant therapy, and inability to undergo antithrombotic therapy; 7) Individuals allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers, and rapamycin; 8) Those who have participated in clinical trials of other drugs or medical devices before being selected but have not reached the primary study endpoint time limit; 9) Researchers have determined that patients have poor compliance and are unable to complete clinical trials as required; 10) Patients undergoing substantial organ transplantation, or those preparing to receive organ transplantation; 11) Unstable arrhythmia, such as high-risk ventricular premature beats and ventricular tachycardia; 12) Due to the need for chemotherapy for tumors; 13) Having immunosuppressive or autoimmune diseases, planning or currently undergoing immunosuppressive therapy; 14) Planned or currently undergoing long-term anticoagulant therapy, such as heparin, warfarin, etc; 15) Patients who have scheduled surgical procedures within six months and need to discontinue aspirin and clopidogrel; 16) The blood routine test indicates that the platelet count is below 100 × 109/L or above 700 × 109/L, and the white blood cell count is below 3 × 109/L; 17) The patient has diffuse peripheral vascular disease and cannot use a 6F catheter. Exclusion criteria for angiography: 1) The target lesion is located in the left main; 2) The target lesion of the right coronary artery (RCA) located at the aorto- ostial (within 3mm of the RCA aortic junction); 3) The target lesion is located within 3mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX); 4) The target lesion involves bifurcation and has the following characteristics: A. Side branch diameter >= 2mm; B. Diameter stenosis >= 50%; C. Side branches require the use of protective guide wires or require pre-expansion. 5) The anatomical structures near or within the target lesion can hinder the delivery of the bioresorbable stent, including: A. Extreme arching (>= 90 °) near or within the target lesion; B. Excessive bending (>= two 45 ° angles) near or within the target lesion; C. Moderate or severe calcification near or inside the target lesion. 6) Dealing with target lesions involves myocardial bridges; 7) Angiography images show the presence of thrombus in the target blood vessel; 8) Prior to the initial surgery, the target vessel had undergone stent treatment, and the bioresorbable stent would need to be implanted to reach the target lesion; 9) The target vessel has undergone stent therapy and the target lesion is located within 5mm proximal to the previously treated lesion; 10) The pre-expanded balloon cannot fully expand at the target lesion site. Complete expansion is based on the following criteria: A. The residual lesion diameter stenosis rate (% DS) must be<= 40% (visual), and it is strongly recommended to be <=20% (visual); B. Blood flow reaches TIMI 3 level (visual inspection); C. No vascular complications (such as distal embolism, collateral occlusion); D. NHLBI grade D-F type without interlayer; E. No sustained chest pain (>5 minutes) and no ST segment depression or elevation lasting>5 minutes. RCT and single arm: The general exclusion criteria of RCT and single arm: 1) Any acute myocardial infarction within one week or CK-MB not returning to normal after myocardial infarction; 2) Patients who have had any stent implanted into the target vessel within one year and plan to undergo interventional treatment again within six months; 3) Severe heart failure (NYHA class III or above) or left ventricular ejection fraction<30% (ultrasound or left ventricular angiography); 4) Preoperative renal dysfunction: serum creatinine>176 μ mol/L;or currently undergoing hemodialysis treatment; 5) Patients with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, history of ischemic stroke within six months, contraindications to antiplatelet and anticoagulant therapy, and inability to undergo antithrombotic therapy; 6) Individuals allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers, and rapamycin; 7) Those who have participated in clinical trials of other drugs or medical devices before being selected but have not reached the primary study endpoint time limit; 8) Researchers have determined that patients have poor compliance and are unable to complete clinical trials as required; 9) Patients undergoing substantial organ transplantation, or those preparing to receive organ transplantation; 10) Unstable arrhythmia, such as high-risk ventricular premature beats and ventricular tachycardia; 11) Due to the need for chemotherapy for tumors; 12) Having immunosuppressive or autoimmune diseases, planning or currently undergoing immunosuppressive therapy; 13) Planned or currently undergoing long-term anticoagulant therapy, such as heparin, warfarin, etc; 14) Patients who have scheduled surgical procedures within six months and need to discontinue aspirin and clopidogrel; 15) The blood routine test indicates that the platelet count is below 100 × 10 9/L or above 700 × 10 9/L, and the white blood cell count is below 3 × 10 9/L; 16) The patient has diffuse peripheral vascular disease and cannot use a 6F catheter. The exclusion criteria for angiography of RCT and Single arm are the same as the FIM.

研究实施时间：

Study execute time：

从 From 2016-11-23 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2019-07-23 00:00:00 至 To 2021-07-05 00:00:00  

干预措施：

Interventions：

组别：

试验组（FIM）

样本量：

30

Group：

Test group (FIM)

Sample size：

干预措施：

全降解冠脉药物洗脱支架系统

干预措施代码：

Intervention：

Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)

Intervention code：

组别：

试验组（RCT）

样本量：

214

Group：

Test group (RCT)

Sample size：

干预措施：

全降解冠脉药物洗脱支架系统

干预措施代码：

Intervention：

Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)

Intervention code：

组别：

对照组（RCT）

样本量：

214

Group：

Control group (RCT)

Sample size：

干预措施：

海利欧斯（HELIOS） 药物支架系统

干预措施代码：

Intervention：

HELIOS drug stent system

Intervention code：

组别：

试验组（单臂）

样本量：

786

Group：

Control group (Single arm)

Sample size：

干预措施：

全降解冠脉药物洗脱支架系统

干预措施代码：

Intervention：

Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京大学第一医院(FIM和RCT) 

单位级别：

三甲 

Institution
hospital：

PEKING UNIVERSITY FIRST HOSPITAL(FIM and RCT)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京安贞医院(FIM和RCT) 

单位级别：

三甲 

Institution
hospital：

Beiing Anzhen Hospital. capitaedical University(FIM and RCT)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 黑龙江 

市(区县)：

  

Country：

China 

Province：

Heihongjiang 

City：

 

单位(医院)：

大庆油田总医院(RCT) 

单位级别：

三甲 

Institution
hospital：

DAQING OILFIELD GENERAL HOSPITAL(RCT)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国人民解放军总医院(RCT) 

单位级别：

三甲 

Institution
hospital：

CHINESE PLA GENERAL, HOSPITALCHINESE PLA MEDICA SCHOOL(RCT)

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京积水潭医院(RCT) 

单位级别：

三甲 

Institution
hospital：

BEIJING JISHUITAN HOSPITAL(RCT)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后180天的支架内及病变节段内晚期管腔丢失（FIM)

指标类型：

主要指标

Outcome：

Late lumen loss within the stent and lesion segment 180 days after surgery(FIM)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

30天靶病变失败（TLF）率（FIM)

指标类型：

主要指标

Outcome：

30 day target lesion failure (TLF) rates(FIM)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

180天靶病变失败（TLF）率（FIM)

指标类型：

主要指标

Outcome：

180 day target lesion failure (TLF) rates

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后365天的支架节段内晚期管腔丢失(RCT)

指标类型：

主要指标

Outcome：

Late stage lumen loss within stent segment 365 days after surgery(RCT)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后365天靶病变失败（TLF）的发生率 (Single arm)

指标类型：

主要指标

Outcome：

Incidence of target lesion failure (TLF) 365 days after surgery (Single arm)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

即刻成功率（FIM/RCT/Single arm）

指标类型：

次要指标

Outcome：

Instant Success Rate (FIM/RCT/Single arm)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后30天（FIM/RCT/Single arm）

指标类型：

次要指标

Outcome：

Clinical evaluation: 30 days after surgery (FIM/RCT/Single arm)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后90天（FIM）

指标类型：

次要指标

Outcome：

Clinical evaluation: 90 days after surgery (FIM)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后180天（FIM/RCT/Single arm）

指标类型：

次要指标

Outcome：

Clinical evaluation: 180 days after surgery (FIM/RCT/Single arm)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术后分析所有血管造影终点（FIM/RCT）

指标类型：

次要指标

Outcome：

Post operative analysis of all vascular imaging endpoints (FIM/RCT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后 180 天分析所有血管造影终点（FIM）

指标类型：

次要指标

Outcome：

180 days after surgery operative analysis of all vascular imaging endpoints (FIM)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后2年（RCT）

指标类型：

次要指标

Outcome：

Clinical evaluation: 2-year postoperative randomized controlled trial (RCT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后3年（RCT）

指标类型：

次要指标

Outcome：

Clinical evaluation: 3-year postoperative randomized controlled trial (RCT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床评价：术后365天（RCT/Single arm）

指标类型：

次要指标

Outcome：

Clinical evaluation: 365 days postoperatively (RCT/Single arm)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后 365 天分析所有血管造影终点（RCT）

指标类型：

次要指标

Outcome：

365 days after surgery operative analysis of all vascular imaging endpoints (RCT)

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：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 79 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）：

采用区组随机，试验开始前由专门的统计学人员生成相应的随机分组表，采用中央随机系统的方式对入组患者进行随机

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

With block randomization, the corresponding randomization table is generated by specialized statisticians before the start of the study, and the enrolled patients are randomized by means of a central randomization system.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

非盲

Blinding：

Open label

是否共享原始数据：

IPD sharing

Yes

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）：

EDC: FIM, http://39.96.78.40/amttsEDC/RedirectAction/toURL.ejw?url=cra/init.jsp; RCT,http://47.107.145.115/amtrctEDC/RedirectAction/toURL.ejw?url=cra/init.jsp

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

EDC: FIM, http://39.96.78.40/amttsEDC/RedirectAction/toURL.ejw?url=cra/init.jsp; RCT,http://47.107.145.115/amtrctEDC/RedirectAction/toURL.ejw?url=cra/init.jsp

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：

FIM,http://39.96.78.40/amttsEDC/RedirectAction/toURL.ejw?url=cra/init.jsp; RCT,http://47.107.145.115/amtrctEDC/RedirectAction/toURL.ejw?url=cra/init.jsp；

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

FIM,http://39.96.78.40/amttsEDC/RedirectAction/toURL.ejw?url=cra/init.jsp; RCT,http://47.107.145.115/amtrctEDC/RedirectAction/toURL.ejw?url=cra/init.jsp;

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-06-20 15:50:02