Italian Diffuse/Multivessel Disease ABSORB Prospective Registry Under the Auspices of Società Italiana di Cardiologia Invasive-GISE (IT-DISAPPEARS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- the cumulative hierarchical incidence of major adverse cardiac events (MACE) defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
研究概览
简要总结
The purpose of this study is to determine whether patients with diffuse or multivessel coronary artery disease may benefit from the percutaneous implantation of the device ABSORB in larger extent with respect to the general population of patients undergoing percutaneous treatment of coronary artery disease.
详细描述
REGISTRY OBJECTIVE
To investigate the procedural as well as the long-term clinical performance of the ABSORB technology in patients with an indication to percutaneous coronary intervention for:
- multivessel disease (at least two significant stenosis in 2 different coronary arteries), or
- long (>24 mm) single vessel disease.
REGISTRY FLOW AND CLINICAL FOLLOW-UP SCHEDULE
The Italian National Registry is a prospective multi-center nation-wide registry evaluating the safety and clinical outcomes of the Absorb BVS in daily use in patients with de novo lesions in previously untreated vessels with indication to PCI for multivessel or long single coronary artery disease.
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 must be at least 18 years of age at the time of signing the Informed Consent Form
- •Patient is to be treated for de novo lesions located in previously untreated vessels.
- •Patient must agree to undergo all required follow-up visits and data collection.
- •Patient must have indication to percutaneous coronary intervention for:
- •multivessel disease (at least two significant stenoses in two different segments NOT as a bifurcation lesion; for patients with two vessel disease at least 1 lesion must be >24 mm and must be treated with the BVS; for patients with 3 vessel disease a hybrid approach is acceptable provided that 2 vessels are treated with BVS),
- •long (>24 mm) single vessel disease following:
- •Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or
- •Unstable angina / non ST-elevation myocardial infarction
- •ST-elevation myocardial infarction with de novo culprit lesion.
排除标准
- •Known intolerance to any of the device components
- •Contraindication to dual antiplatelet therapy (DAPT)
- •Lesion in a saphenous vein graft
- •Lesion to left internal mammary artery
- •Unprotected left main stenosis
- •Woman with childbearing potential
- •Age < 18y/o
- •Concomitant indication to open heart surgery
- •Inability to provide written informed consent
- •Enrolment in another study within 1 month
结局指标
主要结局
the cumulative hierarchical incidence of major adverse cardiac events (MACE) defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
时间窗: 30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.
次要结局
- All causes mortality, clinically driven TLR, clinically driven target vessel revascularization (TVR), any revascularisation (non TLR, non TVR) and ARC-defined stent thrombosis, at any time point, any type of angina.(30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.)
研究者
Luca Testa
MD, PhD
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio