A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study

Launched by SUPIRA MEDICAL · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Supira System, a device designed to support blood circulation during a specific heart procedure called HRPCI (Heart Revascularization Percutaneous Coronary Intervention). The main goal is to see if this system is safe and effective for patients who need help with their heart function during the procedure. The trial is not yet recruiting participants, but it will include adults aged 18 to 90 years who are stable and scheduled for this heart procedure. However, people with certain serious heart conditions or other specific health issues will not be eligible to participate.

If someone qualifies for this trial, they can expect to receive the Supira System during their HRPCI procedure and will be closely monitored for safety and effectiveness. Participants will need to provide informed consent, meaning they agree to take part in the study after understanding what it involves. It’s important for potential participants to know that there are strict criteria for joining, so not everyone will be eligible. This study aims to improve heart treatment options, and the findings could help many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years and ≤90 years
• • 2. Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary 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 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 IABP or any other circulatory support device at time of screening.
• • 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 valve 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 repair
• • 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 active systemic 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 prior or post index procedure
• • 17. Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
• • 18. Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure
• • 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 would have them be considered in any way to be part of a vulnerable population. This includes individuals who may have difficulty providing informed consent or are at a higher risk of coercion or undue influence, individuals permanently incapable of giving informed consent, and individuals whose ability to comply with study procedures may be compromised, in the opinion of the Investigator