Status: Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
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).
Participants needed: 358
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Supira MedicalUpdated: Jun 11, 2026Locations: 14
Eligibility criteria
Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI,... [+1]
Cardiogenic shock or acutely decompensated pre-existing chronic heart failure [+12]