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New heart pump takes on impella in High-Stakes stenting trial

NCT ID NCT07296744

Disease control Sponsor: Supira Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 8 times

Summary

This study compares a new temporary heart pump called the Supira System to the existing Impella pump in 358 patients undergoing high-risk coronary stenting. The goal is to see if Supira is as safe and effective at supporting the heart during the procedure. Participants are randomly assigned to receive one of the two pumps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supira System (temporary heart pump device)
What this could lead to
If it works, this could offer a safer or more effective temporary heart support option during high-risk stenting procedures.
What could go wrong
This is a relatively early-stage device trial with 358 participants, so results may not apply to all patients. There are risks like bleeding, stroke, or kidney injury common to these procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 358 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease High risk percutaneous coronary intervention Interventional cardiology Mechanical circulatory support

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baylor Scott & White The Heart Hospital

    RECRUITING

    Plano, Texas, 75093, United States

  • CentraCare

    RECRUITING

    Saint Cloud, Minnesota, 56362, United States

  • Cuimc/Nyph

    RECRUITING

    New York, New York, 10032, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Health / St. John Hospital

    RECRUITING

    Detroit, Michigan, 48236, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Los Robles Regional Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • OHSU

    RECRUITING

    Portland, Oregon, 97239, United States

  • OhioHealth

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Hillcrest Medical

    RECRUITING

    Tulsa, Oklahoma, 74104, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Prisma Health

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Buffalo (Buffalo General)

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wellspan York Hospital

    RECRUITING

    York, Pennsylvania, 17403, United States

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