Assessing the Supira System for heart procedures

Feasibility Study SA of the Supira System for HRPCI

This study is testing a new heart device called the Supira System to see if it can safely help patients with severe heart issues during risky heart procedures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Supira Medical (industry)
• Locations: 2 sites (São Paulo and 1 other locations)
• Trial ID: NCT05864248 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and safety of the Supira System, a temporary ventricular support device, in patients undergoing high-risk percutaneous coronary interventions (HRPCI). It is a prospective, single-arm, interventional multi-center study that aims to enroll up to 100 subjects. The Supira Catheter is designed to assist in unloading the left ventricle by transporting blood into the aorta during these critical procedures. The study focuses on hemodynamically stable patients with severe coronary artery disease who require additional support during HRPCI.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who are scheduled for elective or urgent HRPCI and require hemodynamic support.

Not a fit: Patients experiencing cardiogenic shock, acute heart failure, or significant neurological deficits from prior strokes may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide critical hemodynamic support to patients undergoing high-risk heart procedures, potentially improving outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using temporary support devices during high-risk cardiac procedures.

Eligibility criteria

To be eligible, subjects must meet ALL of the following inclusion criteria:

1. Age ≥ 18 and ≤ 90 years
2. Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team
3. Signed the informed consent

To be eligible, subjects must NOT meet ANY of the following exclusion criteria:

1. 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.
2. Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
3. Evidence of left ventricular thrombus
4. Moderate or greater aortic valvular disease or regurgitation (≥ 2+ on a 4-grade scale as assessed on transthoracic echo cardiogram (TTE)
5. Moderate or greater aortic stenosis (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 device
9. Presence of decompensated liver disease; severe liver dysfunction (Child class C)
10. Patients requiring renal replacement therapy with dialysis
11. Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy
12. Current or history of heparin-induced thrombocytopenia (HIT)
13. Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, 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 previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
20. 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
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)

Where this trial is running

São Paulo and 1 other locations

• Instituto Dante Pazzanese De Cardiologia (Dante) — São Paulo, Brazil (RECRUITING)
• 'Instituto Do Coração de São Paulo (InCor)' — São Paulo, Brazil (RECRUITING)

Study contacts

• Study coordinator: Veronica Fraser

Conditions: Heart Diseases, Coronary Artery Disease, Heart Failure, High-risk percutaneous coronary intervention, Peripheral ventricular assist device, Supira System