Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

A regiszterben nem jelölt feltételek

• 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
  • 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)