Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Early Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) - The SUPPORT I Trial

Conditions
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Ventricular Assist Device

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 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 Informed consent granted by the patient or legally authorized representative Exclusion Criteria: Cardiogenic shock or acutely decompensated pre-existing chronic heart failure Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit Evidence of left ventricular thrombus as assessed by TTE Aortic valvular disease or regurgitation categorized as moderate or greater (≥ 2+ on a 4-grade scale as assessed on TTE) Aortic stenosis categorized as moderate or greater (gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE) Previous aortic valve replacement or reconstruction Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device Presence of decompensated liver disease; severe liver dysfunction (Child class C) Ongoing renal replacement therapy with dialysis Infection of the proposed procedural access site or systemic active infection requiring ongoing antibiotic therapy Heparin-induced thrombocytopenia (HIT), current or any prior occurrences 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 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) Any condition or scheduled surgery that will require discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure Planned coronary intervention within 30 days post index procedure 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 prior COVID-19 diagnosis with sequelae that could confound endpoint assessments 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 Considered to be part of a vulnerable population

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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No

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
Interventional Model Description: The study is a prospective, non-randomized, single-arm, multicenter, feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supira System<br>Ventricular support indicated for use during elective or urgent high-risk percutaneous coronary interventions. | Device: Supira System<br>* The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a high-risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Successful initiation and maintenance of hemodynamic support | Successful initiation and maintenance of hemodynamic support without severe hypotension throughout the index procedure. Severe hypotension is defined as sustained mean arterial pressure (MAP) < 55 mmHg requiring inotropic/pressor medications and/or alternative mechanical circulatory support. | From device delivery through device removal (up to 4 hours) | 
| Safety - Rate of composite major device-related adverse events (MDRAE) | Rate of composite major device-related adverse events (MDRAE), device delivery through device removal. MDRAEs are defined as any events that are adjudicated by the CEC as definitely, possibly, or probably related to the Supira System. | From device delivery through device removal (up to 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Rate of technical success, defined as completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful removal of the Catheter | From device delivery through device removal (up to 4 hours) | 
| Procedural Success | Rate of procedural success, defined as the rate of technical success without procedural serious adverse events (SAEs) | From device delivery through device removal (up to 4 hours) | 
| Composite major MDRAE | Rate of composite major device-related adverse events (MDRAE) from device removal through hospital discharge | From discharge through 30 days post device removal | 
| Composite MDRAE | Rate of composite MDRAE from hospital discharge through 30 days post device removal | From discharge through 30 days post device removal |