Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Supira Medical
Summary
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
Description
The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the asc…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team * Informed consent granted by the subject 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 * Left ventricular thrombus * Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of…
Interventions
- DeviceThe Supira System
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.
- DeviceImpella
The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i
Locations (7)
- UC DavisSacramento, California
- Piedmont Heart InstituteAtlanta, Georgia
- Henry Ford Health / St. John HospitalDetroit, Michigan
- CentraCareSaint Cloud, Minnesota
- Cuimc/NyphNew York, New York
- Montefiore Medical CenterThe Bronx, New York