NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
| NCT ID | NCT07296744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Supira Medical |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 358 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 358 participants in total. It began in 2026-05-11 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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 the investigational device or the comparator device * Ongoing renal replacement therapy with dialysis * 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 * Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07296744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07296744 currently recruiting?
Yes, NCT07296744 is actively recruiting participants. Contact the research team at clinical@supiramedical.com for enrollment information.
Where is the NCT07296744 trial being conducted?
This trial is being conducted at Loma Linda, United States, Sacramento, United States, Thousand Oaks, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT07296744 clinical trial?
NCT07296744 is sponsored by Supira Medical. The trial plans to enroll 358 participants.