Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease
Brief 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.
Interventions
DEVICEMedtronic Endeavor Coronary Stent System
coronary stent implantation
DEVICEDESyne BD Novolimus Stent System
coronary stent implantation
DEVICEDESyne Novolimus Stent System
coronary stent implantation
Sponsors
Elixir Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss assessed by QCA | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Device-oriented Composite Endpoints | 1, 6, 9, and 12 months and annually to 5 years |
Countries
Australia, Belgium, Brazil, Germany, Netherlands, New Zealand, Poland, Switzerland
Outcome results
None listed