Feasibility Study SA of the Supira System for HRPCI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.
研究概览
简要总结
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
详细描述
The Feasibility Study SA is a prospective, single-arm, interventional multi-center study enrolling up to 100 treated subjects.
The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta.
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team 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
- •To be eligible, subjects must meet ALL of the following inclusion criteria:
- •Age ≥ 18 and ≤ 90 years
- •Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
- •Signed the informed consent
- •To be eligible, subjects must NOT meet ANY of the following
排除标准
- •Cardiogenic shock or acutely decompensated pre-existing chronic heart failure. Cardiogenic shock is defined as: systemic hypotension (systolic 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
- •Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
- •Moderate or greater aortic stenosis (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 device
- •Presence of decompensated liver disease; severe liver dysfunction (Child class C)
- •Patients requiring renal replacement therapy with dialysis
- •Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
- •Current or history of heparin-induced thrombocytopenia (HIT)
- •Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors, or nitinol
- •Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous 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 previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- •Subject has 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)
研究组 & 干预措施
HRPCI patients
Patients undergoing non-emergent, high-risk percutaneous coronary interventions.
干预措施: Supira System (Device)
结局指标
主要结局
Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure.
时间窗: From device delivery through device removal (up to 4 hours).
Sustained hypotension is defined as sustained mean arterial pressure (MAP) \< 60mmHg requiring (1) more than one administration of inotropes/vasopressors within 5 minutes, OR (2) continuous infusion of inotropic/pressor medications, OR 3) alternative mechanical circulatory support, to restore hemodynamics.
Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal.
时间窗: From device delivery through device removal (up to 4 hours).
MDRAEs related to the device.
次要结局
- Rate of Technical Success.(From device delivery through device removal (up to 4 hours).)
- Rate of 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 comes first.(From device removal through hospital discharge or 72 hours post-procedure, whichever occurs first.)
- Rate of composite MDRAE 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))
- Rate of composite MDRAE from 30 days to 90 days post device removal (for subjects enrolled and treated after the first 30 subjects).(From 30 days to 90 days post device removal.)