Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - Destiny Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 10
- 主要终点
- Lumen Loss
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.
详细描述
This is a study of non-inferiority, multicentre, prospective, randomized into two treatment arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a total of 165 randomized patients.
Patients will be followed for 60 months after the procedure. All new patients will be undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months. It is anticipated that the total study duration is 72 months: 12 months to complete the admission of patients and 60 months of follow-up.
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
- 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
- •Age > 18 years;
- •Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
- •A(s) lesion(s) to target(m) must be:
- •Again (not restenotic);
- •Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
- •Can be treated with a single stent up to 29 mm in length;
- •Obstruction with stenosis > 50% diameter (visual);
- •Acceptable candidate for CABG;
- •The patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local Ethics Committee.
排除标准
- •Women of childbearing age with no history of surgical sterilization;
- •Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
- •Myocardial infarction with or without Q wave with cardiac markers even at high levels;
- •Ejection fraction < 30%;
- •Impaired renal function (creatinine> 2.0 mg / dl) or calculated creatinine clearance < 60 ml / min;
- •Platelet count <100,000 cells/mm3 or > 700,000 cells/mm3;
- •Total leukocyte count <3000 cells/mm3;
- •Documented or suspected liver disease (including laboratory evidence of hepatitis);
- •Heart transplant recipient;
- •Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
- •Patient with a life expectancy less than 12 months;
- •Any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study;
- •Participation in other research in the last 12 months, unless there is direct benefit to the research subject;
- •Coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel;
- •Coronary angioplasty (with or without stenting) prior to any time in that segment Diste less than 5 mm (proximal or distal) of the lesion;
- •Coronary angioplasty (with or without stenting) scheduled in the first 12 months after the index procedure in any segment of the target vessel.
- •EXCLUSION CRITERIA angiographic
- •Restenotic target lesion;
- •Need for treatment for more than one lesion in the same vessel;
- •Need for treatment with three or more lesions in the same procedure;
- •Target vessel diameter <2.5 mm or> 3.5 mm (visual);
- •Target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator;
- •Lesion of the coronary artery unprotected ( > 50% stenosis);
- •Angiographic thrombus;
- •Target lesion in surgical graft;
- •Total occlusion (TIMI anterograde flow 0 or 1);
- •Ostial lesion;
- •The target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting;
- •Injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator;
- •The target vessel with excessive tortuosity.
研究组 & 干预措施
Inspiron Stent
Stent Inspiron with Sirolimus
干预措施: Inspiron Stent (Device)
Biomatrix Flex Stent
Stent Biomatrix Flex with biolimus
干预措施: Biomatrix Flex Stent (Device)
结局指标
主要结局
Lumen Loss
时间窗: 9 months after the procedure
For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site. A subgroup of 60 patients will be evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21 patients will be evaluated with optical coherence tomography at the end of the index procedure and 9 months.
次要结局
- Adverse Cardiac Events(30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.)