NL-OMON32462撤回3 期
A Prospective, Multi-Center, Single Arm Study of the Conor Cobalt Chromium Reservoir Based Stent (Nevo) with Sirolimus Elution in Native Coronary Artery Lesions (CP-07 protocol) - Conor RES-ELUTION II NR study
Conor Medsystems, LLC (maakt deel uit van Johnson & Johnson); contact persoon Emily Hergenreter0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria:;-1 Subjects with atherosclerotic CAD ;
- •-2 The subject must be >/= 18 years of age;
- •-3 Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B&C) OR OR non-ST segment elevation myocardial infarction >= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test;
- •-4 Indicated treatment of up to two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel). The target vessel diameter must be >/= 2.25mm and -5 Target lesion length -6 The target lesion has been successfully crossed with the intracoronary guidewire which is positioned intraluminally in the distal vessel;
- •-7 The target lesion diameter stenosis is >50% and <100% based on a visual estimate.
排除标准
- •Exclusion Criteria:;-1 ST-elevation MI within 72 hours prior to the index procedure and/or creatine kinase (CK) >2 times the local laboratory upper limits of normal on the day of the index procedure;
- •-2 The patient has undergone target vessel revascularization within 6 months prior to the intended enrolment procedure.
- •-3 Prior stent within 5 mm of target lesion(s);
- •-4 Ostial target lesion(s);
- •-5 Unprotected left main coronary disease with >/= 50% stenosis;
- •-6 Angiographic evidence of thrombus within target lesion(s);
- •-7 Total coronary occlusion or TIMI grade 0 or 1 in the target vessel;
- •-8 Bifurcation disease involving a side branch >/= 2 mm in diameter;
- •-9 Target lesion(s) within a coronary bypass graft;
- •-10 Significant calcification or angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment;
- •-11 Recipient of heart transplant;
- •-12 Subject with a life expectancy less than 12 months;
- •-13 Known allergies to the following: aspirin, any thienopyridine, heparin, cobalt chromium, contrast agent (that cannot be managed medically), or sirolimus that cannot be managed medically;
- •-14 The patient has contraindication to ASA or to any thienopyridine agent.
- •-15 Known bleeding or hypercoagulable disorder;
- •-16 Known or suspected active infection at the time of the study procedures;
- •-17 Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study, or planned coronary PCI through the end of the study;
- •-18 The patient is currently taking systemic immunosuppressant therapy;
- •-19 Documented left ventricular ejection fraction (EF) < 25%;
- •-20 Impaired renal function (creatinine > 250 micromoles/l or > 2.5 mg/dl) at the time of treatment.
研究者
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