E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive)
2015年10月26日 更新者:Medtronic Bakken Research Center
E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry
The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.
This prospective multi-center study has been initiated:
- To document the acute and mid-term safety and overall clinical performance of the stent system in a "real world" patient population requiring stent implantation.
- To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
研究概览
研究类型
观察性的
注册 (实际的)
8314
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
Real-world patients requiring drug eluting stent implantation
描述
Inclusion Criteria:
- Patient is >18 years of age (or minimum age as required by local regulation)
- The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
- The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions.
- Lesion length and vessel diameter of the target lesion(s) are according to the "Indications for Use" as mentioned in the "Instructions for Use" that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System.
- The patient is willing and able to cooperate with registry procedures and required follow up visits.
Exclusion Criteria:
- Women with known pregnancy or who are lactating.
- Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Current medical condition with a life expectancy of less than 12 months.
- The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this 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
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 |
---|---|---|
MACE (Major Adverse Cardiac Events)
大体时间:12 Months
|
MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))
|
12 Months
|
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。
调查人员
- 首席研究员:Ian T Meredith, MD、Monash Medical Centre, Melbourne, Australia
- 首席研究员:Chaim Lotan, MD、Hadassah University Hospital, Jerusalem, Israel
- 首席研究员:Martin T Rothman, MD、London Chest Hospital, London, United Kingdom
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
- Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138.
- Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.
- Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M. doi: 10.1016/j.amjcard.2007.08.026.
- Lotan C, Meredith IT, Mauri L, Liu M, Rothman MT; E-Five Investigators. Safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: 12-month data from the E-Five registry. JACC Cardiovasc Interv. 2009 Dec;2(12):1227-35. doi: 10.1016/j.jcin.2009.10.001. Erratum In: JACC Cardiovasc Interv. 2010 Feb;3(2):264.
- Jain AK, Lotan C, Meredith IT, Feres F, Zambahari R, Sinha N, Rothman MT; E-Five Registry Investigators. Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: results from the E-Five Registry. Heart. 2010 Jun;96(11):848-53. doi: 10.1136/hrt.2009.184150.
- Meredith I, Rothman M, Erglis A, Parikh K, Lotan C; E-Five Investigators. Extended follow-up safety and effectiveness of the Endeavor zotarolimus-eluting stent in real-world clinical practice: two-year follow-up from the E-Five Registry. Catheter Cardiovasc Interv. 2011 Jun 1;77(7):993-1000. doi: 10.1002/ccd.22803. Epub 2010 Dec 3.
- Lotan C, Meredith IT, Jain A, Feres F, Firszt A, Garcia AF, Rothman MT. Clinical outcomes by geographic region for patients implanted with the zotarolimus-eluting stent. Arq Bras Cardiol. 2011 May;96(5):353-62. doi: 10.1590/s0066-782x2011005000033. Epub 2011 Apr 1. English, Portuguese, Spanish.
- Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE; ENDEAVOR III Investigators. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006 Dec 19;48(12):2440-7. doi: 10.1016/j.jacc.2006.08.035. Epub 2006 Nov 28.
有用的网址
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
2005年9月1日
初级完成 (实际的)
2007年11月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2008年2月18日
首先提交符合 QC 标准的
2008年2月25日
首次发布 (估计)
2008年2月26日
研究记录更新
最后更新发布 (估计)
2015年11月23日
上次提交的符合 QC 标准的更新
2015年10月26日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Endeavor Zotarolimus Eluting Coronary Stent的临床试验
-
Seoul National University Bundang Hospital完全的