Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

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 high-risk percutaneous coronary interventions (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.

Use of the Supira System in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and postprocedural adverse events

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤90 years
2. Presents with hemodynamic stability and need for 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

Exclusion Criteria:

1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
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 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 cm2 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 (HIT), 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 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