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

Supira Medical · NCT07296744

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
358
US sites recruiting
25
Study start
May 11, 2026
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: The Supira System; Impella

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Loma Linda University Medical Center

    Loma Linda, CA 92354

    Site contact: Vinoy Prasad, M.D. · 909-558-4200 · khefflin@llu.edu

  • UC Davis

    Sacramento, CA 95817

    Site contact: Garrett Wong, M.D.

  • Los Robles Regional Medical Center

    Thousand Oaks, CA 91360

    Site contact: Saibal Kar, M.D. · 805-852-9100 · mane.arabyan@hcahealthcare.com

  • University of Miami

    Miami, FL 33136

    Site contact: Barbara Lang · 305-243-4950 · blang@med.miami.edu

  • Piedmont Heart Institute

    Atlanta, GA 30309

    Site contact: David Kandzari, M.D.

  • Emory University Hospital

    Atlanta, GA 30322

    Site contact: Bill Nicholson, M.D. · wei.xu@emory.edu

  • Northside Hospital

    Lawrenceville, GA 30046

    Site contact: Troy Crain · 678-312-3828 · Troy.Crain@northside.com

  • Northwestern University

    Chicago, IL 60611

    Site contact: Joaquim Barboza, M.D. · 312-664-3278 · droshevs@nm.org

  • Henry Ford Health / St. John Hospital

    Detroit, MI 48236

    Site contact: Amir Kaki, M.D.

  • CentraCare

    Saint Cloud, MN 56362

    Site contact: Stephen Kidd, M.D.

  • Washington University in St. Louis

    St Louis, MO 63110

    Site contact: John Lasala, M.D. · 314-362-1291 · cjenifer@wustl.edu

  • Virtua Health

    Camden, NJ 08103

    Site contact: Kristin Wade · 856-355-1225 · KMWADE@virtua.org

  • University of Buffalo (Buffalo General)

    Buffalo, NY 14203

    Site contact: Vijay Iyer, M.D. · 716-710-8266 · ehejna@buffalo.edu

  • Cuimc/Nyph

    New York, NY 10032

    Site contact: Megha Prasad, M.D.

  • Montefiore Medical Center

    The Bronx, NY 10467

    Site contact: Andrea Mignatti, M.D.

  • Mission Health

    Asheville, NC 28803

    Site contact: Josie Routhier · 828-274-6001 · Josephine.Routhier@HCAHealthcare.com

  • OhioHealth

    Columbus, OH 43214

    Site contact: Arash Arshi, M.D. · 614-262-6772 · joanna.flores-jones@ohiohealth.com

  • Oklahoma Heart Hillcrest Medical

    Tulsa, OK 74104

    Site contact: Kamran Muhammad, M.D.

  • Providence

    Portland, OR 97225

    Site contact: Sheryl Ames · 503-216-2099 · Sheryl.Ames@providence.org

  • OHSU

    Portland, OR 97239

    Site contact: Firas Zahr, M.D. · 503-494-1775 · sampsonna@ohsu.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Joyce Wald, D.O. · 215-615-4949 · alyson.brown@pennmedicine.upenn.edu

  • Wellspan York Hospital

    York, PA 17403

    Site contact: Rhian Davies, D.O. · 717-851-5153 · hmckinney@wellspan.org

  • Prisma Health

    Columbia, SC 29203

    Site contact: Vince Vismara, M.D. · 803-434-3800 · Suzanne.Smith@PrismaHealth.org

  • Baylor Scott & White The Heart Hospital

    Plano, TX 75093

    Site contact: Karim Al-Azizi, M.D. · 469-800-6300 · Osniel.GonzalezRamos@BSWHealth.org

  • Intermountain Health

    Murray, UT 84107

    Site contact: Savanna Chhak · 801-507-4731 · Savanna.Chhak@imail.org

Study contacts (from the official record)

  • Supira Medical · (669) 330-0883 · clinical@supiramedical.com
  • Chris DeMorett
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Pivotal Study of the SUpira System in Patients Undergoing… (NCT07296744) | Bored Studies