Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 358
- 试验地点
- 25
- 主要终点
- Composite Safety and Efficacy Outcomes
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
详细描述
The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
- •Informed consent granted by the subject or legally authorized representative
排除标准
- •Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- •Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- •Left ventricular thrombus
- •Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device
- •Ongoing renal replacement therapy with dialysis
- •Presence of decompensated liver disease; severe liver dysfunction
- •Infection of the proposed procedural access site or active infection
- •Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
- •Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- •Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
- •Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
- •Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
- •Considered to be part of a vulnerable population per the investigator's assessment
研究组 & 干预措施
Supira System
Subjects receiving the Supira System
干预措施: The Supira System (Device)
Impella
Subjects receiving the Impella
干预措施: Impella (Device)
结局指标
主要结局
Composite Safety and Efficacy Outcomes
时间窗: 30 days
* All-cause death * Myocardial infarction * Stroke or transient ischemic attack * Major bleeding * Major access site-related vascular complications * Acute Kidney Injury * Unplanned repeat revascularization * Sustained hypotensiona during mechanical circulatory support * Arrythmia requiring cardioversion during pump use
次要结局
- Secondary Outcome Measures(30 and 90 days)