NCT05466552招募中不适用
A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients
Fondazione GISE Onlus1 个研究点 分布在 1 个国家目标入组 859 人开始时间: 2022年10月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 859
- 试验地点
- 1
- 主要终点
- Cerebrovascular accident
研究概览
简要总结
The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System.
详细描述
The PROTECT-EU Registry is a prospective multinational registry on preventive left ventricular support with Impella in high-risk PCI treated patients. The aim is to confirm and improve the Impella effectiveness in a selected all comers high risk population undergoing supported HR-PCI (high risk-PCI) with Impella implantation before PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-emergent chronic or acute coronary syndromes (the former refused from surgical revascularization) with reduced LVEF (left ventricular ejection fraction)(<=40%) and indication for high-risk PCI AND
- •Intended high-risk PCI defined as having at least one of the following criteria:
- •Unprotected left main distal disease involving bifurcation or trifurcation or left main equivalent
- •Diffuse degenerated (>5 mm) saphenous vein grafts involving the proximal or distal anastomosis or in-stent restenosis
- •LAD (left anterior descending) long lesions (>48 mm) involving both septal and diagonal branches requiring multiple and overlapping stents
- •Diffuse and severely calcified lesions (see protocol definition) with need for debulking devices (directional, rotational, orbital, and laser)
- •Last patent conduit
- •Complex CTO (chronic total occlusion) (J-CTO score 3) or CTO in patients with MVD (Coronary Microvascular Disease)
- •MV-PCI (Multivessel Percutaneous Coronary Intervention) in patient with a Syntax score>32 undergoing planned complete revascularization (see protocol definition of severe stenosis)
- •(only in ACS Acute Coronary Syndrome patients) Giant thrombus (length ≥3x vessel diameter) in the context of MVD or Syntax score >32.
排除标准
- •Classic CS Coronary Sinus (relative hypotension as SBP < 90 mmHg, or MAP <60 mmHg or >30 mmHg drop from baseline and drugs/device used to maintain blood pressure above these targets and/or symptoms/signs of hypoperfusion as cardiac index <2.2, lactate ≥ 2mmol/L (24).
- •Cardiac arrest
- •Patients admitted for ACS due to ST-elevation MI (ST Elevation Myocardial Infarction)
- •Contraindication to Impella positioning: mural thrombus in the left ventricle; presence of a mechanical aortic valve; severe aortic stenosis or valvular regurgitation; severe peripheral arterial disease precluding placement of the Impella System; haematological disorder causing fragility of the blood cells or hemolysis; hypertrophic obstructive cardiomyopathy (HOCM); aneurysm or severe anomaly of the ascending aorta and/or aortic arch; significant right heart failure; presence of an atrial or ventricular sepal defect (including post-infarct VSD Ventricular Septal Defect); left ventricular rupture; cardiac tamponade; recent TIA or stroke (within 1 month); contraindication to anticoagulation
- •Age < 18 or > 80 years old
- •Inability to understand and sign informed consent
- •Serious known concomitant disease with a life expectancy of less than one year
- •Prior thrombolytic therapy during the index event (within 72 h of presentation)
- •Severe renal impairment Renal insufficiency (GFR Glomerular Filtration Rate <30 ml/min)
- •Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban) at the time of PCI
- •Suspected or known pregnancy
- •Suspected active infection
- •Current participation in an investigational study using a drug or device.
结局指标
主要结局
Cerebrovascular accident
时间窗: at 90 days
Cerebrovascular accident at 90 days
infarction
时间窗: at 90 days
myocardial infarction
revascularization
时间窗: at 90 days
repeat revascularization
Death
时间窗: at 90 days
Composite endpoint of all-cause death
次要结局
- QoL: KCCQ(at 1 year)
- cerebrovascular events(at 1 year)
- hospitalization for cardiovascular cause(at 1 year)
- QoL: EQ-5D(at 1 year)
研究者
研究点 (1)
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