NCT00489541已完成3 期
A Prospective Evaluation in a Non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 28
- 主要终点
- In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)
研究概览
简要总结
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20 mm in length in native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.
详细描述
This is a prospective, multi-center, single-arm superiority trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of ≤20 mm in length in native coronary arteries with visual RVD of ≥ 2.25 mm to < 2.75 mm diameter.
Two hundred twenty-four (224) subjects will be treated with the TAXUS Element stent at a maximum of 35 clinical sites. Follow-up at 30 days, 9 months including angiography) and 1 year will be completed in all subjects enrolled in the study. Eligible subjects will have annual follow-up until 5 years post-index procedure.
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
- •Clinical Inclusion Criteria:
- •Subject is ≥ 18 years old
- •Eligible for percutaneous coronary intervention (PCI)
- •Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
- •Acceptable candidate for coronary artery bypass grafting (CABG)
- •Left ventricular ejection fraction (LVEF) is ≥ 30%
- •Subject (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
- •Subject willing to comply with all specified follow-up evaluations
排除标准
- •Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine
- •Known hypersensitivity to paclitaxel
- •Known allergy to stainless steel
- •Known allergy to platinum
- •Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
- •Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
- •Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
- •Previous treatment with intravascular brachytherapy in the target vessel
- •Planned PCI or CABG post-index procedure
- •Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
- •Myocardial infarction (MI) within 72 hours prior to index procedure
- •Cerebrovascular accident (CVA) within the past 6 months
- •Cardiogenic shock
- •Acute or chronic renal dysfunction
- •Prior anaphylactic reaction to contrast agents
- •Leukopenia
- •Thrombocytopenia
- •Thrombocytosis
- •Active peptic ulcer or active gastrointestinal (GI) bleeding
- •Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents
- •Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
- •Known intention to procreate within 9 months after the index procedure
- •Positive pregnancy test within 7 days before the index procedure, or lactating
- •Life expectancy of less than 24 months due to other medical conditions
- •Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity
- •Currently participating in another investigational drug or device study
- •Angiographic Inclusion Criteria:
- •Target Lesion
- •Target lesion located in native coronary artery
- •Target lesion must be de novo
- •Target lesion diameter stenosis ≥ 50%
- •Reference vessel diameter (RVD) ≥ 2.25 mm to < 2.75 mm
- •Cumulative target lesion length ≤ 20 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent)
- •Target lesion is successfully pre-dilated
- •One non-target lesion may be treated in a non-target vessel as follows:
- •Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required
- •Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s)
- •Treatment must be completed prior to treatment of target vessel
- •Angiographic Exclusion Criteria:
- •Target lesion located in left main artery, whether protected or unprotected
- •Target lesion is a chronic total occlusion (TIMI flow ≤ 1)
- •Target lesion is restenotic
- •Target lesion is located in a saphenous vein graft or mammary artery graft
- •Target lesion is accessed via saphenous vein graft or mammary artery graft
- •Target lesion is < 5 mm from bare metal stent (BMS)
- •Target lesion < 5 mm from ostium
- •Target lesion < 5 mm from side branch vessel ≥ 2.0 mm in diameter (Exceptions: subject may be enrolled if side branch is 100% occluded or if side branch is protected with a patent graft)
- •Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel at a location with ≥ 2.0mm RVD
- •Target lesion and/or target vessel proximal to target lesion moderately severely calcified
- •Target lesion and/or target vessel proximal to target lesion severely tortuous
- 另有 4 项未显示
研究组 & 干预措施
TAXUS Element Stent System
Experimental
干预措施: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation (Device)
结局指标
主要结局
In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)
时间窗: 9 months post-index procedure
Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.
次要结局
- Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.(12 months post-index procedure)
研究者
研究点 (28)
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