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E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive Registry)
This study is ongoing, but not recruiting participants.
Sponsored by: Medtronic Bakken Research Center
Information provided by: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00623441
  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

MedlinePlus related topics: Coronary Artery Disease
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, 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 [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 8000
Study Start Date: September 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endeavor Zotarolimus Eluting Coronary Stent
    Drug eluting 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
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

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
Publications indexed to this study:
Responsible Party: Medtronic Bakken Research Center ( Sofia Pateraki/Clinical Research Specialist Vascular )
Study ID Numbers: Protocol version1.1_19-07-2005
Study First Received: February 18, 2008
Last Updated: February 25, 2008
ClinicalTrials.gov Identifier: NCT00623441  
Health Authority: Not required: N/A

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009