First-in-Human (FIH) Clinical Investigation Protocol of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions (ELEVATE I)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Device Performance
研究概览
简要总结
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.
详细描述
The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients.
The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis)
- •Ejection fraction of ≤ 45% and at least one of the following:
- •Intervention on an unprotected left main coronary artery
- •Intervention on a last patent coronary conduit
- •Three-vessel disease (in case of left coronary artery dominance, the combination of a Left Anterior Descending Artery (LAD) lesion and a proximal Left Circumflex Artery (LCX) lesion qualifies as three-vessel disease)
- •Femoral artery diameter compatible with the use of Elevate™
- •Subject signed informed consent
排除标准
- •Subject age < 40 or ≥ 83 years
- •Cardiogenic shock
- •Left ventricular mural thrombus
- •Presence of a mechanical aortic valve or a heart-constrictive device
- •Aortic stenosis
- •Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography)
- •Severe peripheral vascular disease
- •Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device
- •Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL)
- •Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L)
- •Active systemic infection
- •Stroke or transient ischemic attack within 3 months of enrollment
- •Female subjects who are pregnant or breast-feeding
结局指标
主要结局
Device Performance
时间窗: Through the end of the procedure
Rate of procedural hypotension
Device Safety
时间窗: Through the end of the procedure
Rate of Major Device-Related Adverse Events
次要结局
未报告次要终点