E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
Coronary Artery Disease	Device: Endeavor Zotarolimus Eluting Coronary Stent

Study Design

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Study Type :	Observational
Actual Enrollment :	8314 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry
Study Start Date :	September 2005
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	February 2009

Groups and Cohorts

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Intervention Details:

Device: Endeavor Zotarolimus Eluting Coronary Stent
Drug eluting stent
Other Name: Endeavor Stent

Outcome Measures

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Primary Outcome Measures :

1. MACE (Major Adverse Cardiac Events) [ Time Frame: 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))

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Real-world patients requiring drug eluting stent implantation

Criteria

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.

Contacts and Locations

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Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Principal Investigator:	Ian T Meredith, MD	Monash Medical Centre, Melbourne, Australia
Principal Investigator:	Chaim Lotan, MD	Hadassah University Hospital, Jerusalem, Israel
Principal Investigator:	Martin T Rothman, MD	London Chest Hospital, London, United Kingdom

More Information

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Additional Information:

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Publications of Results:

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.

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. Epub 2011 Apr 1. English, Portuguese, Spanish.

Other Publications:

Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel 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. Epub 2006 Aug 14.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Epub 2006 Nov 28.

Responsible Party:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00623441 History of Changes
Obsolete Identifiers:	NCT00265668
Other Study ID Numbers:	Protocol Final version1.1
First Posted:	February 26, 2008
Results First Posted:	December 16, 2011
Last Update Posted:	November 23, 2015
Last Verified:	October 2015

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Coronary Artery Disease; Drug-eluting stent

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases