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Study of the Supira System for High-Risk Heart Procedures

This study is testing a new device called the Supira System. It's designed to help your heart during high-risk percutaneous coronary intervention (HRPCI), a procedure to open blocked heart arteries. The Supira System is a temporary pump that helps your heart by moving blood from your heart into your main artery. We want to see if it's safe and effective compared to another device called Impella, which is already available. You could be eligible if you are 18 to 90 years old, need an elective or urgent HRPCI, and your heart team thinks you need support during the procedure. We are looking for about 358 participants. The study is currently unclear on its recruitment status.

Study design
This study will randomly assign participants to receive either the investigational Supira System or the Impella device during their heart procedure. It aims to enroll 358 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and how well the treatment works will be checked for 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07296744

Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Recruiting
NAAges 18–90InterventionalTreatment
Supira Medical
~358 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:The Supira SystemImpella

At a glance

Recruiting sites
17 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Safety and Efficacy Outcomes
Measured over 30 days

Conditions

Coronary Artery Disease
High Risk Percutaneous Coronary Intervention
Interventional Cardiology
Mechanical Circulatory Support

Explore related trials

Coronary Artery Disease

Where it's being run

19 sites across 13 states
California3
New York3
Georgia2
Pennsylvania2
Illinois1
Michigan1
Minnesota1
Missouri1

Who to contact

Supira Medical
[email protected]
(669) 330-0883
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

What this trial measures

  • Composite Safety and Efficacy Outcomes30 days

    * All-cause death * Myocardial infarction * Stroke or transient ischemic attack * Major bleeding * Major access site-related vascular complications * Acute Kidney Injury * Unplanned repeat revascularization * Sustained hypotensiona during mechanical circulatory support * Arrythmia requiring cardioversion during pump use