Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 262
- 试验地点
- 4
- 主要终点
- Percentage Diameter Stenosis
研究概览
简要总结
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
详细描述
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently represents the dominant treatment strategy in patients undergoing catheter intervention. However effective neointimal suppression occurs at the cost of a systematic delay in arterial healing in comparison with after bare metal stenting. This underlies a small but significant increased risk of stent thrombosis after DES implantation in comparison with bare metal stent implantation as well as a possible excess of in-stent neoatheroma formation.
Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing short-term vessel scaffolding and drug delivery without the long-term limitations of metallic DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent bypass grafting of the stented arterial segment. In addition preliminary reports suggest that the process of scaffold biodegradation may promote formation of a cohesive tissue layer covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing effect. Although initial results with BVS are encouraging, there is a lack of randomized clinical trial data and no data exists for outcomes after BVS implantation in patients undergoing coronary stenting in the setting of acute myocardial infarction (MI).
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2 years.
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
- •Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
- •Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
- •In women with childbearing potential a negative pregnancy test is mandatory
排除标准
- •Target lesion located in the left main trunk
- •Severely calcified lesions
- •Bifurcation lesions with side branch diameter > 2mm
- •In-stent restenosis
- •Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
- •Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrolment in this trial
- •Patient's inability to fully cooperate with the study protocol
研究组 & 干预措施
Bioresorbable vascular scaffold
Bioresorbable vascular scaffold (BVS)
干预措施: Bioresorbable vascular scaffold (Device)
Everolimus-eluting stent
Durable polymer everolimus-eluting metallic stent (EES)
干预措施: Durable polymer everolimus-eluting metallic stent (Device)
结局指标
主要结局
Percentage Diameter Stenosis
时间窗: 6-8 months
Percentage diameter stenosis at coronary angiography at 6-8 months follow-up
次要结局
- Device-oriented composite endpoint(12 months)
- Patient-oriented composite endpoint(12 months)
- Composite of death or MI(12 months)
- Stent thrombosis(12 months)