TAXUS ATLAS SMALL VESSEL: A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 48
- 主要终点
- Percent diameter stenosis - analysis segment at 9 months
研究概览
简要总结
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical TAXUS Express control derived from a subset of lesion-matched TAXUS V patients treated with a 2.25 mm stent. The objective of the study is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels.
详细描述
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.
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 at least 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 at least 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 avaiable bare metal stent, heparin-coated stent or TAXUS Express stent.
- •Successful predilation is mandatory for entry into study
- •Target lesion located within a single native coronary artery
- •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.
- •Cumulative target lesion length is greater than or equal to 10 mm and less than or equal to 28 mm (visual estimate)
- •Target lesion RVD of 2.25 mm [2.2 - 2.5 mm (visual estimate)]
- •Target lesion diameter stenosis at least 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.
- •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 within 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
- •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:
- •Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)
- •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 >1.5 mm (visual estimate)
- •Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation
- •Angiographic presence of probable or definite thrombus
- •Pre-treatment of teh target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon
- •A previously treated lesion within the target vessel:
- •<15mm from the target lesion (visual estimate)
- •Performed </= 6 months from index procedure
- •>30% residual stenosis after previous treatment
结局指标
主要结局
Percent diameter stenosis - analysis segment at 9 months
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)
- Target Vessel Revascularization (TVR)(5 Years)
- QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)(9 months)