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

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

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.

Inclusion Criteria:

• 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.

• Subject has single vessel disease or has multivessel disease with only moderate stenosis (max 50-60% or total occlusion (100%) for which no interventions are planned at the time of study inclusion).

• Target lesion / vessel must meet the following criteria:

  1. 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
  2. Target vessel must be a native coronary artery with a stenosis of >=50% and <100%
  3. Target lesion must be >= 14 mm and ≤ 27 mm in length
  4. 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

Exclusion Criteria:

• 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:

  1. Lesion location is aorto-ostial, an unprotected left main lesion, or within 5mm of the origin of the LAD, LCX, or RCA
  2. Involves a side branch >2.0 mm in diameter
  3. Is at or distal to a 45º bend in the vessel
  4. Is severely calcified

• Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)

• History of a stroke or transient ischemic attack within the prior 6 months

• Active peptic ulcer or upper GI bleeding within the prior 6 months

• The subject has a 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 with anti-restenotic therapies including, but not limited to, drug-eluting stents and 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