The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial

NCT00217256 | Completed DMC

• 1 other identifier: IP056
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter.

Conditions

Coronary Artery Disease

Keywords

Restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment late lumen loss

  8 months

Secondary Outcomes (10)

• Device Success

  9 months

• Lesion Success

  9 months

• Procedure Success

  9 months

• Major Adverse Cardiac Event (MACE) rate

  30 days, 6, 9, and 12 months

• Target Site Revascularization (TSR) rate and clinically-driven TSR rate

  9 months

Study Arms (2)

1

EXPERIMENTAL

Endeavor Drug Eluting Stent

Device: Percutaneous Coronary Stenting

2

ACTIVE COMPARATOR

Cypher Drug Eluting Stent

Device: Percutaneous Coronary Stenting

Interventions

Percutaneous Coronary Stenting DEVICE

Endeavor Drug Eluting Stent

1

Eligibility Criteria

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

You may qualify if:

• The patient is at least 18 years of age.
• The patient must have clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
• The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
• Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
• The patient 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 of the respective clinical site.
• The patient and the treating physician agree that the patient will return to the treating research center, or an affiliated institution under the same IRB jurisdiction, for all required post-procedure follow-up visits. A research staff member who has been properly trained to the Endeavor III protocol must conduct all follow-up evaluations.

You may not qualify if:

• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• History of an allergic reaction or significant sensitivity to drugs similar to ABT-578 (rapamycin or rapamycin analog).
• A platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a WBC \< 3,000 cells/mm³.
• A creatinine level \> 2.0 mg/dL.
• Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase (CK) enzymes greater than or equal to 2X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) elevated above the Institution's upper limit of normal).
• Any previous or planned treatment of any vessel with a drug eluting stent.
• Previous or planned percutaneous coronary intervention of any vessel within 30 days pre or post procedure.
• Previous stenting anywhere in the target vessel.
• During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
• History of a stroke or transient ischemic attack within the prior 6 months.
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS) or other coronary artery imaging procedures.

Sponsors & Collaborators

• Medtronic Vascular: lead

Related Publications (3)

• Kandzari DE, Mauri L, Popma JJ, Turco MA, Gurbel PA, Fitzgerald PJ, Leon MB. Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2011 May;4(5):543-50. doi: 10.1016/j.jcin.2010.12.014.

  PMID: 21596327 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, Leon MB, Kandzari DE, Mauri L, Edwards R, Kong DF, Cowper PA, Anstrom KJ; ENDEAVOR III Investigators. Long-term clinical and economic analysis of the Endeavor zotarolimus-eluting stent versus the cypher sirolimus-eluting stent: 3-year results from the ENDEAVOR III trial (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1199-207. doi: 10.1016/j.jcin.2009.10.009.

  PMID: 20129546 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin B. Leon, M.D.

  Columbia University College of Physicians & Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: December 1, 2010
• Last Updated: June 27, 2011

Record last verified: 2011-06