Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Feasibility: Successful initiation and maintenance of hemodynamic support
研究概览
简要总结
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. The clinical data may be used to support subsequent regulatory applications and further evaluation of the Supira System.
详细描述
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team, including a cardiac surgeon, has determined HRPCI is the appropriate therapeutic option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Subjects will be eligible for inclusion in this study if all of the following criteria apply:
- •Age ≥18 and ≤90 years
- •Subject is hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is needed, as determined by the institutional heart team
- •Informed consent granted by the patient or legally authorized representative
- •Subjects who meet any one of the following criteria will be excluded from study participation:
- •Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
- •a. Note: Cardiogenic shock is defined as: systemic hypotension (systolic blood pressure (BP) <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the following: any requirement for inotropes/pressors prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of intra-aortic balloon pump (IABP), or any other circulatory support device.
- •Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- •Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)
- •Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
- •Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm^2 as assessed on TTE)
- •Previous aortic valve replacement or reconstruction
- •Ascending or descending aortic dissection or aortic aneurysm >4.5 cm
- •Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device
- •Presence of decompensated liver disease; severe liver dysfunction (Child class C)
- •Ongoing renal replacement therapy with dialysis
- •Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
- •Heparin-induced thrombocytopenia, current or any prior occurrences
- •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
- •Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 or known fibrinogen ≤1.5 g/L)
- •Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure
- •Planned coronary intervention within 30 days post index procedure
- •Breastfeeding or pregnant
- •Currently participating in active follow-up phase of another clinical study of an investigational drug or device
- •Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments
- •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 (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
排除标准
- 未提供
研究组 & 干预措施
Supira System
Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions.
干预措施: Supira System (Device)
结局指标
主要结局
Feasibility: Successful initiation and maintenance of hemodynamic support
时间窗: From device delivery through removal (up to 4 hours)
Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Sustained hypotension is defined as sustained mean arterial pressure (MAP) \< 60 mmHg requiring inotropic/pressor medications or alternative mechanical circulatory support.
Safety: Rate of composite major device-related adverse events (MDRAEs), from device insertion through device removal (inclusive of Supira procedure-related SAEs).
时间窗: From device delivery through device removal (up to 4 hours)
MDRAEs are defined as any serious adverse events that are adjudicated by the Clinical Events Committee (CEC) as definitely or probably related to the Supira System.
次要结局
- Technical Success(From device delivery through device removal (up to 4 hours))
- Procedural Success(From device delivery through device removal (up to 4 hours))
- Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.(From device removal through hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.)
- Rate of composite MDRAEs from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.(From hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal.)
- Rate of composite MDRAEs from 30 days to 90 days post device removal.(From 30 days to 90 days post device removal.)