NCT00371709已完成3 期
TAXUS ATLAS: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 871
- 试验地点
- 116
- 主要终点
- 9-Month Target Vessel Revascularization (TVR)
研究概览
简要总结
TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The control group is a case-matched, blended population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.
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
- •Patient is ≥18 years old.
- •Eligible for percutaneous coronary intervention (PCI)
- •Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
- •Left ventricular ejection fraction (LVEF) of >/=25%
- •Acceptable candidate for coronary artery bypass grafting (CABG)
- •Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- •Willing to comply with all specified follow-up evaluations
- •Angiographic Inclusion Criteria:
- •Only one lesion (target lesion) may be treated with the study stent. However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
- •Target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments)but must be completely covered by one study stent.
- •Target lesion located within a single native coronary artery
- •Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
- •RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
- •Target lesion diameter stenosis ≥50% (visual estimate)
- •Target lesion is de novo (i.e., a coronary lesion not previously treated)
排除标准
- •Known hypersensitivity to paclitaxel
- •Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
- •Previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
- •Previous or planned treatment with intravascular brachytherapy in the target vessel
- •Planned CABG ≤9-months post-index procedure
- •MI within 72 hours prior to the index procedure and or creatine kinase(CK) >2x the local laboratory's ULN unless CK-MB is <2x ULN.
- •Cerebrovascular Accident (CVA) within the past 6 months
- •Cardiogenic Shock
- •Acute or chronic renal dysfunction
- •Contraindication to ASA, or to both clopidogrel and ticlopidine
- •Thrombocytopenia or thrombocytosis
- •Active peptic ulcer or active gastrointestinal (GI) bleeding
- •Known allergy to stainless steel
- •Any prior true anaphylactic reaction to contrast agents
- •Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
- •Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
- •Male or female with known intention to procreate within 3 months after the index procedure
- •Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study.
- •Life expectancy of less than 24-months due to other medical condition
- •Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- •Angiographic Exclusion Criteria:
- •Left main coronary artery disease (stenosis >50%) whether protected or unprotected
- •Target lesion is ostial in location (within 3.0 mm of vessel origin)
- •Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate.
- •Target lesion and/or target vessel proximal to the target lesion is tortuous.
- •Target lesion is located within or distal to a >60 degree bend in the vessel
- •Target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.
- •Target lesion is totally occluded (TIMI flow </= 1), either at baseline or predilation
- •Angiographic presence of probable or definite thrombus
- •Pre-treatment of the target vessel is not allowed with any device
结局指标
主要结局
9-Month Target Vessel Revascularization (TVR)
时间窗: 9 Months
次要结局
- Clinical procedural and technical success(5 Years)
- Utilization parameters (equipment utilization; catheters, guidewires and balloons, procedure time, fluoroscopic time and amount of contrast used)(9 Months)
- MACE rates at discharge, 1, 4 and 9-months and 1, 2, 3, 4, and 5 years post-index procedure.(5 Years)
- Stent thrombosis rate(5 Years)
- Target Vessel Failure (TVF)(5 Years)
- QCA parameters (binary restenosis rate, MLD and late loss)(9 Months)
- IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume) for patients in the IVUS subset(9 Months)
研究者
研究点 (116)
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