此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

RESOLUTE China Registry: (R-C Registry)

2018年4月4日更新者：Medtronic Vascular

Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.

研究概览

地位

完全的

条件

详细说明

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

研究类型

观察性的

注册 (实际的)

1800

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- - Beijing、中国、100000
    - Beijing Fumwai Hospital
  - Beijing、中国、100044
    - Peiking University People's Hospital
  - Fuzhou、中国、350001
    - Fujian Medical University Union Hospital
  - Guangdong、中国、510000
    - Guangdong Provincial People's Hospital
  - Nanjing、中国、210006
    - Nanjing First Hospital
  - Wuhan、中国、430022
    - Wuhan Asia Heart Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

描述

Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

Age ≥ 18 years or minimum age as required by local regulations
The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
Intention to electively implant at least one Resolute stent
The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
Women with known pregnancy or who are lactating
High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Previous enrollment in the Resolute China Registry

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：仅案例
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Target lesion failure (TLF) 大体时间：12m	Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.	12m

次要结果测量

结果测量	措施说明	大体时间
Overall stent thrombosis 大体时间：12m	Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.	12m
Device success, Lesion success, Procedural success 大体时间：At the end of the index procedure or during hospital stay		At the end of the index procedure or during hospital stay
TLF 大体时间：30 days, 6 months, 2 year, 3 year, 4 year and 5 year	Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year	30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular) 大体时间：30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year		30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	Q wave and non-Q wave MI	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Revascularization 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	target lesion and target vessel revascularization (TLR and TVR)	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	hemorrhagic in nature	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF) 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE) 大体时间：at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year	a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods	at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medtronic Vascular

调查人员

首席研究员：Jiyan Chen, MD、Guangdong Provincial People's Hospital
首席研究员：Shubin Qiao, MD、Fu Wai Hospital, Beijing, China
首席研究员：Lianglong Chen, MD、Fujian Medical University Union Hospital
首席研究员：Shaoliang Chen, MD、The First Affiliated Hospital with Nanjing Medical University
首席研究员：Weimin Wang, MD、Peiking University People's Hospital
首席研究员：Guoying Zhu, MD、Wuhan Asia Heart Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014 Feb 15;113(4):613-20. doi: 10.1016/j.amjcard.2013.10.042. Epub 2013 Nov 23.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年12月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2017年12月15日

研究注册日期

首次提交

2010年11月17日

首先提交符合 QC 标准的

2010年11月17日

首次发布 (估计)

2010年11月18日

研究记录更新

最后更新发布 (实际的)

2018年4月5日

上次提交的符合 QC 标准的更新

2018年4月4日

最后验证

2018年4月1日