E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent (eFive Registry)
This study has been completed.
Sponsor:
Medtronic Bakken Research Center
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
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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 |
Resource links provided by NLM:
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
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:
Related Info 
Related Info 
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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013