NCT02230254已完成不适用
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Technical Success Rate
研究概览
简要总结
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
详细描述
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion (CI) Criteria
- •Subject must be at least 18 -75 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
- •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
- •Subject has a left ventricular ejection fraction (LVEF) >30% as measured within 60 days prior to enrollment
- •Angiographic Inclusion (AI) 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 ( Target lesion(s) length must be ≤28 mm for reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (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 test or imaging stress test, or elevated biomarkers) prior to procedure
- •Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
- •The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with/or rotational coronary atherectomy, or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
排除标准
- •Clinical Exclusion (CE) Criteria
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week
- •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 pre-medicated) 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, Clopidogrel , 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 12 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 with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
- •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 signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
- •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)
- •CE21.Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
- •Angiographic Exclusion (AE) 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 20 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)
- •Excessive tortuosity proximal to or within the lesion
- •Excessive angulation proximal to or within the lesion
- •Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
- •Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch <2.0 mm in diameter by visual estimate which requires treatment
结局指标
主要结局
Technical Success Rate
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
次要结局
- Target Lesion Failure (TLF) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Target Vessel Revascularization (TVR) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months)
- Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Target Lesion Revascularization (TLR) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Cardiac Death Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Non-cardiac Death Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- All Death Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Cardiac Death or MI Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- All Death or MI Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Longitudinal Stent Deformation (LSD) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Target Vessel Failure (TVF) Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- All Death/MI/TVR Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Clinical Procedural Success Rate(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- In-stent and In-segment Percent Diameter Stenosis (%DS)(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- In-stent and In-segment Minimum Lumen Diameter (MLD)(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
- Acute Gain(Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months)
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