NCT00371423已完成3 期
A Multi-center, Single-arm Study of the TAXUS Liberté™-SR Stent for the Direct Stenting Treatment of Patients With de Novo Coronary Artery Lesions
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 48
- 主要终点
- Analysis segment percent diameter stenosis at 9-months
研究概览
简要总结
TAXUS ATLAS Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus results from patients in whom implantation with the TAXUS Liberté stent was preceded by balloon angioplasty (pre-dilatation). The Control group consists of patients in the main TAXUS ATLAS trial, in which pre-dilatation was mandatory. The primary objective is to compare outcomes of direct stenting with balloon catheter pre-dilatation. The primary hypothesis is that late outcomes with direct stenting of the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System will be non-inferior to conventional implantation with balloon catheter pre-dilatation
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 appropriate for direct stenting (typically covered by one 24 mm stent or shorter), 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 located within a single native coronary vessel
- •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 ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
- •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
- •Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
- •Thrombocytopenia
- •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 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 diseased (>50% stenotic)branch vessel >2.0 mm in diameter
- •Target lesion is totally occluded (TIMI flow<1) at baseline
- •Angiographic presence of probable or definite thrombus
- •Pre-treatment of the target vessel at the index procedure is not allowed with any device
- •A previously treated lesion within the target vessel:
- •<15 mm from the target lesion (visual estimate)
- •Performed </= 6 months from index procedure
- •>30% residual stenosis after previous treatment
- •Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.
研究组 & 干预措施
Arm 2
Other
Control data derived from ATLAS Workhorse Trial
干预措施: TAXUS Liberté™-SR (Device)
Arm 1
Experimental
干预措施: TAXUS Liberté™-SR (Device)
结局指标
主要结局
Analysis segment percent diameter stenosis at 9-months
时间窗: 9 Months
次要结局
- Secondary Endpoints: Clinical procedural and technical success(5 years)
- Stent thrombosis rate(5 Years)
- Utilization parameters (equipment utilization, 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)
- Target Vessel Failure (TVF)(5 Years)
- QCA parameters (binary restenosis rate, in-stent %DS, MLD and late loss)(9 Months)
- IVUS parameters (percent net volume obstruction, incomplete apposition, stent and area volumes, neointimal area volume)(9 Months)
- Target Vessel Revascularization (TVR)(5 Years)
研究者
研究点 (48)
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