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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 135

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful initiation and maintenance of hemodynamic support

Secondary Outcome Measures

Name	Time	Method
Procedural Success

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