ELEVATE High-Risk PCI Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 39
- 主要终点
- A composite of the incidence of major safety and effectiveness parameters.
研究概览
简要总结
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).
详细描述
The Elevate™ percutaneous Left Ventricular Assist Device System 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. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.
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 88 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 on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
- •Baseline (uncorrected) hemoglobin >10.0 g/dl as long as an active source of blood loss has been reasonably excluded.
- •A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
- •Participant signed the informed consent.
排除标准
- •Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
- •Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
- •Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
- •Evidence of left ventricular thrombus.
- •Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
- •Aortic valve regurgitation (AR) > +2 on a 4-grade scale using transthoracic echocardiography.
- •Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
- •Patient on dialysis.
- •Known or suspected coagulopathy OR abnormal coagulation parameters.
- •Known allergy, sensitivity or intolerance to nickel.
- •Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
- •Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
- •Any non-cardiac condition with a life expectancy < 12 months.
- •Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
- •Pregnancy or breast-feeding.
- •Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
- •Subject belongs to a vulnerable population.
研究组 & 干预措施
Impella
Subjects receiving the Impella System
干预措施: Impella (Device)
Elevate
Subjects receiving the Elevate System
干预措施: Elevate (Device)
结局指标
主要结局
A composite of the incidence of major safety and effectiveness parameters.
时间窗: 30 days
A composite of the incidence of: 1. Major Adverse Cardiac and Cerebrovascular Events (MACCE): Death, Myocardial Infarction, Stroke or Transient Ischemic Attack, Unplanned Repeat Revascularization; 2. Major intra-procedural hemodynamic events on Mechanical Circulatory Support: Severe Hypotension, Cardio-Pulmonary Resuscitation or Cardioversion; 3. Major Mechanical Circulatory Support-related access site complications: Vascular Injury Requiring Intervention or Access Site Bleeding.
次要结局
- Major Hemolysis during index hospitalization(Perioperative/Periprocedural)
- Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.(Perioperative/Periprocedural)
- Length of hospital stay(Perioperative/Periprocedural)
- Length of ICU/CCU stay(Perioperative/Periprocedural)