An interventional study of Supira System in Heart Disease, Coronary Arterial Disease (CAD) and Heart Failure, sponsored by Supira Medical. Recruiting at 2 sites in Georgia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Supira Medical · Not applicable, Interventional, and Treatment
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.
The study is a prospective, non-randomized, single-arm, multi-center, feasibility study.
The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI) and requiring hemodynamic support. The Catheter is inserted percutaneously, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
Exclusion Criteria:
Patients undergoing HRPCI with low LVEF and severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure
Device: Supira System
The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing 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. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
Safety
Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events \[SAEs\]).
Time frame: Perioperative/Periprocedural
Feasibility:
Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).
Time frame: Perioperative/Periprocedural
Secondary Study Endpoints
* Rate of technical success * Rate of procedural success * Rate of composite MDRAEs from cath lab discharge to Supira Catheter removal * Rate of composite MDRAEs from Supira Catheter removal to hospital discharge * Rate of MDRAEs from hospital discharge to 30 days
Time frame: 30 days
Plan to share: No
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