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

Coronary Artery Disease Clinical Trial

— eFive  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623441
• Other study ID #: Protocol Final version1.1
• Status: Completed
• Phase: N/A
• First received: February 18, 2008
• Last updated: October 26, 2015
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: October 2015
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Not required: N/A
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00265668

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8314
• Est. completion date: February 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Endeavor Zotarolimus Eluting Coronary Stent
Drug eluting stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

References & Publications (6)

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. — View Citation

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):8 — View Citation

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. — View Citation

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, Spanis — View Citation

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 — View Citation

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 Cardiova — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (Major Adverse Cardiac Events)	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))	12 Months	Yes

External Links

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