Feasibility Study SA of the Supira System for HRPCI

Study Overview
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Brief Summary
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The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.

Detailed Description
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The Feasibility Study SA is planned as a prospective, single-arm, interventional multi-center study enrolling up to 30 subjects. The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta. The Supira System is a temporary ventricular support device indicated for use for a short time during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

Official Title
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Feasibility Study SA of the Supira System for HRPCI

Conditions
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Heart Diseases, Heart Failure

Intervention / Treatment
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* Device: Supira System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 90 years Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team Signed the informed consent Exclusion Criteria: ST-elevation myocardial infarction (STEMI) within 30 days Stroke within 3 months of the index procedure, or prior stroke > 3 months with any permanent neurologic deficit Evidence of left ventricular thrombus Previous aortic valve replacement or reconstruction Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm Previous transcatheter mitral valve replacement or repair Ventricular septal defect Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device Mechanical ventilation due to primary respiratory mechanical dysfunction (e.g., pneumonia, ARDS, pneumothorax) Breastfeeding or pregnant Currently participating in active follow-up phase of another clinical study of an investigational drug or device Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments Considered to be part of a vulnerable population 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRPCI patients<br>Patients undergoing non-emergent, high-risk percutaneous coronary interventions. | Device: Supira System<br>* The Supira System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Device-Related Adverse Events (MDRAE) | The rate of Supira System related Serious Adverse Events | From device delivery through device removal (up to 6 hours) | 
| Successful initiation and maintenance of hemodynamic support without Severe Hypotension | Rate of successful initiation and maintenance of Supira System hemodynamic support without Severe Hypotension | From device delivery through device removal (up to 6 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Supira System Technical Success | Completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful retrieval of the catheter. | From device delivery through device removal (up to 6 hours) | 
| Rate of procedural success | Rate of technical success without procedural serious adverse events (SAEs). | From device delivery through device removal (up to 6 hours) | 
| Rate of composite MDRAE | Rate of composite MDRAE | From discharge through 30 days | 
| Rate of each individual MDRAE | Rate of each individual MDRAE | From time of initiation of index procedure through 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supira, HRPCI