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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00623441
First received: February 18, 2008
Last updated: January 27, 2012
Last verified: September 2009
  Purpose

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 Intervention
Coronary Artery Disease
Device: Endeavor Zotarolimus Eluting Coronary Stent

Study Type: Observational
Study Design: 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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • MACE (Major Adverse Cardiac Events) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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))


Enrollment: 8314
Study Start Date: September 2005
Study Completion Date: February 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endeavor Zotarolimus Eluting Coronary Stent
    Drug eluting stent
    Other Name: Endeavor Stent
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: February 18, 2008
Results First Received: September 1, 2009
Last Updated: January 27, 2012
Health Authority: Not required: N/A

Keywords provided by Medtronic Bakken Research Center:
Coronary Artery Disease
Drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014