A Prospective Registry for the Use of CypherTM Sirolimus-Eluting Stents In Patients With Coronary Artery Disease Treated With Percutaneous Coronary Interventions at Scripps Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 859
- 试验地点
- 1
- 主要终点
- 1 yr target vessel failure (TVF), defined as the occurrence of any of the following within 1-year after the index procedure: death from cardiac causes, Q-wave or non-Q wave MI attributable to the target vessel (TV), or revascularization of the TV.
研究概览
简要总结
This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay).
All patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, TLR, TVR, major or minor bleeding). A follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750 patients will be conducted and data forwarded to FDA.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Eligible for percutaneous coronary intervention
- •Patient has at least one lesion ≥50% diameter stenosis requiring PCI with stenting
- •Reference vessel diameter 2.25-4.0 mm
- •Percutaneous intervention with use of one or more of the FDA approved CypherTM stents, planned not to exceed 108 mm of stent length.
- •Target lesion is located within a native coronary artery or bypass graft
- •De novo and restenotic lesions, including ISR, radiation failure
- •Be reliable, cooperative and willing to comply with all protocol-specified procedures and follow-up
- •Able to understand and grant informed consent
排除标准
- •Confirmed pregnancy at the time of index PCI
- •Has known allergies to aspirin, and to both clopidogrel (PlavixTM) and ticlopidine (TiclidTM)
- •Has known allergies or contraindication to heparin and Bivalirudin (AngiomaxTM)
- •Known allergy or sensitivity to any component of a Sirolimus-eluting stent
- •Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- •Any serious disease condition with life expectancy of less than 1 year.
结局指标
主要结局
1 yr target vessel failure (TVF), defined as the occurrence of any of the following within 1-year after the index procedure: death from cardiac causes, Q-wave or non-Q wave MI attributable to the target vessel (TV), or revascularization of the TV.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Paul S Teirstein, MD
Chief of Cardiology
Scripps Clinic