A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
研究概览
简要总结
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or non-pregnant female patients 18 years of age
- •Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
- •Treatment of a single de novo target lesion in a major native coronary artery;
- •Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
- •Target lesion is 30mm in length (visual estimate);
- •Target lesion stenosis is > 50% and < 100% (visual estimate);
排除标准
- •Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
- •Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
- •Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- •Documented Left ventricular ejection fraction 25%;
- •Totally occluded vessel (TIMI 0 level);
- •Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
研究组 & 干预措施
1
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
干预措施: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) (Device)
结局指标
主要结局
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
时间窗: From post-procedure up to hospital discharge
Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
次要结局
- Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later(From post-procedure up to 30 days)
- Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge(From post-procedure up to hospital discharge)
- Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later(From post-procedure up to 12 months)