NCT01665053已完成3 期
EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,684
- 试验地点
- 247
- 主要终点
- Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
详细描述
A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.
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
- Single (Participant)
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
- •Subject must be at least 18 years of age
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- •For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
- •Subject is eligible for percutaneous coronary intervention (PCI)
- •Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- •Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- •Subject is willing to comply with all protocol-required follow-up evaluation
- •Angiographic Inclusion Criteria (visual estimate):
- •Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
- •Target lesion(s) length must be ≤34 mm (by visual estimate)
- •Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
- •Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
- •The first lesion treated must be successfully predilated/pretreated
排除标准
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
- •Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
- •Subject has received an organ transplant or is on a waiting list for an organ transplant
- •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- •Planned PCI (including staged procedures) or CABG after the index procedure
- •Subject previously treated at any time with intravascular brachytherapy
- •_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
- •Subject has one of the following (as assessed prior to the index procedure):
- •Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
- •Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
- •Planned procedure that may cause non-compliance with the protocol or confound data interpretation
- •Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
- •Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- •Subject has a white blood cell (WBC) count < 3,000 cells/mm3
- •Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
- •Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
- •Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
- •Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
- •Subject has severe symptomatic heart failure (i.e., NYHA class IV)
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
- •Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
- •Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
- •Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- •Angiographic Exclusion Criteria (visual estimate):
- •Planned treatment of more than 3 lesions
- •Planned treatment of lesions in more than 2 major epicardial vessels
- •Planned treatment of a single lesion with more than 1 stent
- •Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
- •Target lesion(s) is located in the left main
- •Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
- •Target lesion(s) is located within a saphenous vein graft or an arterial graft
- •Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
- •Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- •Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- •Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- •Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
- •Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- •Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
研究组 & 干预措施
Promus Element Plus
Active Comparator
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
干预措施: PROMUS Element Plus (Device)
SYNERGY
Experimental
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
干预措施: SYNERGY (Device)
结局指标
主要结局
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
时间窗: 12 months
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
次要结局
- Percentage of Participants With Cardiac Death at 12 Month.(12 months)
- Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.(12 months)
- Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.(12 months)
- Percentage of Participants With Myocardial Infarction at 12 Month.(12 months)
- Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.(12 months)
- Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.(12 Month)
- Percentage of Patients That Died at 12 Months.(12 months)
- Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.(12 months)
- Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.(12 months)
- Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.(12 months)
- Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.(12 months)
- Percentage of Participants With Non-Cardiac Death at 12 Month.(12 months)
- Percentage of Patients With a Stroke at 12 Month.(12 months)
- Periprocedural Technical Success Rate.(Day 1 (periprocedure))
- Periprocedural Clinical Procedural Success Rate(Day 1 (periprocedure))
- Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.(12 month)
研究者
研究点 (247)
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