Compares the Supira System with Impella during high-risk heart artery procedures
Compares the Supira heart support device with Impella in adults having high-risk coronary procedures.
Plain-language title generated from the registry record
Registry title: Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Key facts
- Where
- Asheville, Atlanta, Buffalo, Camden, Chicago, Columbia, Columbus, Detroit, Lawrenceville, Loma Linda, Miami, Murray, New York, Paramus, Philadelphia, Plano, Portland, Sacramento, Saint Cloud, St Louis, The Bronx, Thousand Oaks, Tulsa, and York, United StatesSee the 26 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07296744, who can take part
Where in United States
- Mission HealthAsheville, United StatesTaking people
- Emory University HospitalAtlanta, United StatesTaking people
- Piedmont Heart InstituteAtlanta, United StatesTaking people
- University of Buffalo (Buffalo General)Buffalo, United StatesTaking people
- Virtua HealthCamden, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Prisma HealthColumbia, United StatesTaking people
- OhioHealthColumbus, United StatesTaking people
- Henry Ford Health / St. John HospitalDetroit, United StatesTaking people
- Northside HospitalLawrenceville, United StatesTaking people
- Loma Linda University Medical CenterLoma Linda, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- Intermountain HealthMurray, United StatesTaking people
- Cuimc/NyphNew York, United StatesTaking people
- The Valley HospitalParamus, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Baylor Scott & White The Heart HospitalPlano, United StatesTaking people
- OHSUPortland, United StatesTaking people
- ProvidencePortland, United StatesTaking people
- UC DavisSacramento, United StatesTaking people
- CentraCareSaint Cloud, United StatesTaking people
- Washington University in St. LouisSt Louis, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Los Robles Regional Medical CenterThousand Oaks, United StatesTaking people
- Oklahoma Heart Hillcrest MedicalTulsa, United StatesTaking people
- Wellspan York HospitalYork, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Supira Medical
- Trial code
- NCT07296744
- Record updated
- 2 November 2026
- Original description
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).Read full original descriptionShow less
Pivotal Randomized 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).
Inclusion: 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: Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit; Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device; Ongoing renal replacement therapy with dialysis; Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure; Cardiogenic shock or acutely decompensated pre-existing chronic heart failure; Presence of decompensated liver disease; severe liver dysfunction; Infection of the proposed procedural access site or active infection; 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; Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure; Left ventricular thrombus; Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure; 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 per the investigator's assessment.