elixir medical clinical evaluation of the novolimus-eluting coronary stent system: a randomized study "excella ii study"

Conditions: Coronary Artery Disease

Summary: randomized study to evaluate the safety and effectiveness of the elixir medical desyne novolimus-eluting coronary stent system with durable polymer through the assessment of clinical, angiographic and ivus endpoints as compared to the concurrently enrolled medtronic zotarolimus-eluting coronary stent system in a randomized, single blind study of up to 200 male and female patients. in a continued access registry of up to 100 patients receiving the desyne stent clinical-only endpoints will be evaluated. to evaluate the safety and effectiveness of the elixir novolimus-eluting coronary stent system with bioabsorbable polymer as compared to the medtronic endeavor zotarolimus-eluting coronary stent system control through clinical and angiographic endpoints.


Eligibility criteria:
inclusion criteria: * the patient has a planned intervention of a single lesion in one or two separate major epicardial territories. each lesion/vessel must meet the following criteria: * de novo * the target lesion reference site must be visually estimated to be \> 2.5 mm and \< 3.5 mm in diameter. * the target vessel must be a major coronary artery or major branch with a visually estimated stenosis of \> 50% and \<100%. * the visually estimated target lesion must be able to be covered by a single, 14, 18 or 28mm stent elixir stent or a single 14, 18, 24 or 30mm endeavor stent. note that the 8mm endeavor stent will not be used in this study. * maximum lesion length is 24 mm. * \> timi 1 coronary flow. exclusion criteria: * the patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, mtor inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated. * there will be an untreated significant lesion of \> 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention. * total occlusion or timi 0 coronary flow in the target vessel. * restenosis lesion * the proximal target vessel or target lesion is severely calcified by visual assessment. * aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the lad or lcx. * lesion involvement of a significant side branch (branch diameter \> 2 mm) that would be covered by stenting. * the patient has suffered a myocardial infarction with total creatine kinase (ck) \>2 times normal within the past 72 hours (exactly three days). * the patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * the patient suffered a stroke, transient ischemic neurological attack (tia) or significant gastrointestinal (gi) bleed within the past six months. * the patient has renal insufficiency as determined by a creatinine of \> 2.0mg/dl. * the target lesion, or the target vessel proximal to the target lesion, contains thrombus. * documented left ventricular ejection fraction of \< 25%. * the patient is a recipient of a heart transplant. * the patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion or extreme anti-coagulation.

Keywords: coronary artery disease