NCT00792753已完成不适用
A Randomized, Single Blind, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Durable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions And A Randomized, Consecutive Enrollment Evaluation of the Elixir Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer Compared to the Medtronic Endeavor Zotarolimus-Eluting Coronary Stent System in the Treatment Of Patients With De Novo Native Coronary Artery Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 16
- 主要终点
- In-stent late lumen loss assessed by QCA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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.
结局指标
主要结局
In-stent late lumen loss assessed by QCA
时间窗: 9 months
次要结局
- Device-oriented Composite Endpoints(1, 6, 9, and 12 months and annually to 5 years)
研究者
研究点 (16)
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