E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive)
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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MACE (Major Adverse Cardiac Events)
Prazo: 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))
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12 Months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Ian T Meredith, MD, Monash Medical Centre, Melbourne, Australia
- Investigador principal: Chaim Lotan, MD, Hadassah University Hospital, Jerusalem, Israel
- Investigador principal: Martin T Rothman, MD, London Chest Hospital, London, United Kingdom
Publicações e links úteis
Publicações Gerais
- 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- Protocol Final version1.1
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