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

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ClinicalTrials.gov Identifier: NCT00623441
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : December 16, 2011
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

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 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


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))



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623441


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

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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    Key Record Dates
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