NCT01122719终止不适用
The Best Trial - Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen
CID - Carbostent & Implantable Devices2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- In-stent late lumen loss
研究概览
简要总结
To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.
详细描述
The present study is a post-market, prospective, international, two-center, single arm study involving 60 patients with single, de novo non-complex coronary lesions.
Enrolled patients will be asked to return for follow-up clinical evaluation at 1, 6, 12 and 24 months. At 3 months there will be an additional follow-up by phone contact.
Furthermore, the first 15 patients should undergo angiographic and OCT follow-up at two months. The remaining 45 patients should undergo angiographic and IVUS follow-up at 8 months.
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 with >18 years of age;
- •Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
- •Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
- •Acceptable candidate for coronary artery bypass graft(CABG)surgery;
- •The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups,including angiographic, IVUS and OCT assessments.
- •Single, de novo lesion
- •Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by on-line QCA)
- •Target lesions ≤19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
- •≥50% and <100% diameter stenosis;
- •TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥2.
排除标准
- •Known hypersensitivity or contraindication to tacrolimus, heparin,any required medications including thienopyridines, and contrast media which cannot be adequately pre medicated;
- •Patient is a female with childbearing potential;
- •Pre-treatment of the target lesion with any devices other than balloon angioplasty;
- •Previous brachytherapy in the target vessel;
- •Presence of non-target vessel lesions which require staged procedure(s) <30 days of the index procedure;
- •Prior CABG surgery to target vessel;
- •Previous percutaneous coronary intervention (PCI) or CABG surgery <30 days to the index procedure date;
- •Acute myocardial infarction <3 days, with cardiac enzyme elevation including total creatine kinase (CK) >2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
- •CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
- •Documented left ventricular ejection fraction <30%;
- •Renal insufficiency determined by a baseline serum creatinine >2.0 mg/dl;
- •Thrombocytopenia with a baseline platelet count <100,000 cells/mm3;
- •Anemia with baseline hemoglobin <10g/dL;
- •Extensive peripheral vascular disease or extreme anticoagulation that precludes safe >5 French sheath insertion;
- •History of bleeding diathesis, coagulopathy, or refusal of blood transfusions;
- •Patients has suffered a stroke, transient ischemic attack (TIA),or cerebrovascular accident (CVA) within the past 6 months;
- •Significant gastrointestinal or genitourinary bleed within the past 6 months;
- •Patient is a recipient of a heart transplant;
- •Any elective surgical procedure is planned within 12 months of the index procedure;
- •Known illness or any serious clinical condition with life expectancy <2 years;
- •Participation in the active or follow-up phase of any other clinicaltrial within 6 months;
- •Impossibility to comply with anti-platelet therapy during the study clinical follow-up;
- •Any impossibility to comply with all protocol follow-ups.
- •Target lesion or vessel with angiographic evidence of moderate or severe calcification;
- •Presence of severe tortuosity;
- •Presence of severe angulation (>60o);
- •Presence of intraluminal thrombus;
- •Target lesion involving a bifurcation (side branch ≥2.0mm);
- •Target lesion located in the left main stem;
- •Aorto-ostial lesion location;
- •Target lesion involving a side branch with reference diameter≥2.0mm;
- •Presence of a significant stenosis (>40%) in the target vessel either proximal or distal to the target lesion that will be untreated;
- •Previous placement of a stent within 10mm of the target lesion;
- •Total occlusion (TIMI flow grade 0 or 1);
- •Target lesion located in an arterial or vein graft;
- •Target lesion due to in-stent restenosis;
- •Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.
结局指标
主要结局
In-stent late lumen loss
时间窗: 8-month
次要结局
- All-cause and cardiac mortality;(up to 24 months)
- Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual(up to 24 months)
- Major Adverse Cardiac Event (MACE) defined as a composite of cardiac death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG(up to 24 months)
- Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late(up to 24 months)
- Stent strut coverage assessed by OCT(2 months)
- Late acquired incomplete stent apposition by IVUS(8-month)
- In stent & In segment angiographic parameters(8-month)
- Clinically Driven TLR(up to 24 months)
- Clinically Driven TVR(up to 24 months)
- Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR)(up to 24 months)
研究者
研究点 (2)
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