NCT00217269已完成不适用
A Randomized, Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 1,548 人开始时间: 2005年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,548
- 试验地点
- 1
- 主要终点
- Target vessel failure (TVF) rate
研究概览
简要总结
The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.
详细描述
The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- •The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
- •Female patients of childbearing potential must have a negative pregnancy test within 7 days before the procedure.
- •The patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.
- •The patient agrees to return to the same research facility for all required post-procedure follow-up visits.
排除标准
- •A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., Phosphorylcholine or Translute), or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- •History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative.
- •History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
- •A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
- •A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- •Evidence of an acute MI within 72 hours of the intended index procedure (defined as: QWMI or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal).
- •Previous PCI of the target vessel within 9 months pre-procedure.
- •Planned PCI of any vessel within 30 days post-procedure.
- •During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (including but not limited to, cutting balloon, any atherectomy, any laser, thrombectomy, etc.).
- •History of a stroke or transient ischemic attack (TIA) within the prior 6 months.
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
- •Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.
- •Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
结局指标
主要结局
Target vessel failure (TVF) rate
时间窗: 9 months
次要结局
- Angiographic parameters (in-stent and in-segment) including: percent diameter stenosis (%DS)(8 months)
- Late lumen loss (in-segment late lumen loss is a powered secondary endpoint)(9 months)
- Late loss index(9 months)
- Angiographic binary restenosis (ABR) rate(9 months)
- Minimum luminal diameter (MLD)(9 months)
- Major adverse cardiac event (MACE) rate(30 days, 6, 9, and 12 months)
- Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)(8 months)
- Target site revascularization (TSR) rate and clinically-driven TSR rate(9 months)
- Target vessel revascularization (TVR) rate and clinically-driven TVR rate(9 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
RESOLUTE ONYX China RCT StudyIschemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesArteriosclerosisCoronary Artery DiseaseNCT03466151Medtronic Vascular550
进行中（未招募）
不适用
HF-TRACK: A UK RCT of an Passive Heart Failure Monitoring and Tracking DeviceHeart FailureNCT06334822Heartfelt Technologies186
已完成
1 期
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal CancerMetastatic Colorectal CancerNCT01008475Merck KGaA, Darmstadt, Germany232
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B VaccineHepatitis B, ChronicNCT04289987CHA Vaccine Institute Co., Ltd.134
已完成
不适用
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)Dermatitis, AtopicNCT03672383Bayer42