Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial

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.

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.

Subjects will be eligible for inclusion in this study if all of the following criteria apply:

1. Age ≥18 and ≤90 years
2. 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
3. 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:

1. 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.

2. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit

3. Evidence of left ventricular thrombus as assessed by Transthoracic Echocardiogram (TTE)

4. Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)

5. Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm^2 as assessed on TTE)

6. Previous aortic valve replacement or reconstruction

7. Ascending or descending aortic dissection or aortic aneurysm >4.5 cm

8. Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device

9. Presence of decompensated liver disease; severe liver dysfunction (Child class C)

10. Ongoing renal replacement therapy with dialysis

11. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy

12. Heparin-induced thrombocytopenia, current or any prior occurrences

13. 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

14. 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)

15. Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure

16. Planned coronary intervention within 30 days post index procedure

17. Breastfeeding or pregnant

18. Currently participating in active follow-up phase of another clinical study of an investigational drug or device

19. Active COVID-related infection or prior COVID-19 diagnosis with sequelae that could confound endpoint assessments

20. 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

21. 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)