The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions

NCT00614848 | Completed DMC

• 1 other identifier: IP034
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases; Coronary Disease; Coronary Arteriosclerosis; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Ischemia; Arteriosclerosis

Keywords

restenosis

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure Rate at 9 months post procedure

  9 months

Secondary Outcomes (1)

• Device Success Lesion Success Procedure Success Major Cardiac Adverse Events (MACE) at 30 days and 6, 9, and 12 months, and annually thereafter out to 5 years. Late loss at 8 months as measured by QCA

  30 days and 6, 9, and 12 months, and annually thereafter out to 5 years.

Study Arms (2)

1

EXPERIMENTAL

Endeavor Drug Eluting Coronary Stent

Device: Endeavor drug eluting coronary stent

2

ACTIVE COMPARATOR

Driver bare-metal coronary stent

Device: Endeavor drug eluting coronary stent

Interventions

Endeavor drug eluting coronary stent DEVICE

Zotarolimus coated coronary stent (10ug/mm)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is an acceptable candidate for PTCA, stenting, and emergent CABG.
• Subject must have clinical evidence of ischemic heart disease or a positive functional study.
• Target lesion / vessel must meet the following criteria:
• Target lesion is a single de novo lesion that has not been previously treated with any interventional procedure. Only one lesion may be treated per subject
• Target vessel must be a native coronary artery with a stenosis of \>=50% and \<100%
• Target lesion must be \>= 14 mm and ≤ 27 mm in length
• Target vessel reference diameter must be \>= 2.25 mm and ≤3.5 mm
• Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
• Subject or subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site
• Subject and treating physician agree that subject will comply with all required post-procedure follow-up

You may not qualify if:

• A documented left ventricular ejection fraction \<30%
• A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, cobalt, nickel, chromium, or a sensitivity to contrast media, which cannot be adequately pre-medicated
• History of an allergic reaction or significant sensitivity or receiving drugs similar to/or synergistic to ABT-578 (rapamycin, tacrolimus, sirolimus, CCI-779 or other analogues).
• A platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a WBC \<3,000 cells/mm³
• Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes \>2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal).
• Creatinine \>2.0 mg/dl
• A previous coronary interventional procedure of any kind within the 30 days prior to the procedure
• Subject requires planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
• Target lesion requires treatment with a device other than PTCA prior to stent placement
• Previous stenting anywhere in the target vessel
• Target vessel has evidence of thrombus or is excessively tortuous (2 bends \>90 degrees to reach the target lesion)
• Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off
• Target lesion located in native vessel distally to anastomosis with vein graft or LIMA
• Target lesion has any of the following characteristics:
• Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the LAD, LCX, or RCA

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

Dr. J. Fajedet

Clinique Pasteur, France

Location

Related Publications (4)

• Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel 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. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.

  PMID: 16908773 RESULT

• Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021.

  PMID: 21232717 DERIVED

• Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138.

  PMID: 20142198 DERIVED

• Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1178-87. doi: 10.1016/j.jcin.2009.10.011.

  PMID: 20129543 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Vascular Diseases; Ischemia; Arteriosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• J. Fajadet, MD

  Clinique Pasteur, France

  PRINCIPAL INVESTIGATOR

• Richard E Kuntz, MD, MSc

  Harvard Medical School, USA

  PRINCIPAL INVESTIGATOR

• W. Wijns, MD, PhD

  OLV Hospital, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: June 1, 2003
• Primary Completion: January 1, 2005
• Study Completion: July 1, 2009
• Last Updated: April 11, 2011

Record last verified: 2011-04

Locations

FR (1)