Recruiting

Supira vs. Impella

Sponsor:

Supira Medical

Code:

NCT07296744

Conditions

Coronary Artery Disease

High Risk Percutaneous Coronary Intervention

Interventional Cardiology

Mechanical Circulatory Support

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

The Supira System

Impella

Study Details

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).

Conditions

Coronary Artery Disease

High Risk Percutaneous Coronary Intervention

Interventional Cardiology

Mechanical Circulatory Support

Study ID

NCT07296744

Start date

May 11, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

358 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Supira System

Subjects receiving the Supira System

active comparator: Impella

Subjects receiving the Impella

Interventions

The Supira System

The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.

Impella

The current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i

Primary outcome measure

  • Composite Safety and Efficacy Outcomes [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Supira Medical

(669) 330-0883clinical@supiramedical.com

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Vinoy Prasad, M.D.

909-558-4200khefflin@llu.edu

Principal Investigator:

VInoy Prasad, M.D.

UC Davis

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Garrett Wong, M.D.

Los Robles Regional Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Saibal Kar, M.D.

805-852-9100mane.arabyan@hcahealthcare.com

Principal Investigator:

Saibal Kar, M.D.

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

David Kandzari, M.D.

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Joaquim Barboza, M.D.

312-664-3278droshevs@nm.org

Principal Investigator:

Joaquim Barboza, M.D.

Henry Ford Health / St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Principal Investigator:

Amir Kaki, M.D.

CentraCare

Recruiting

Saint Cloud, Minnesota, United States, 56362

Principal Investigator:

Stephen Kidd, M.D.

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

John Lasala, M.D.

314-362-1291cjenifer@wustl.edu

Principal Investigator:

John Lasala, M.D.

University of Buffalo (Buffalo General)

Recruiting

Buffalo, New York, United States, 14203

Contacts

Vijay Iyer, M.D.

716-710-8266ehejna@buffalo.edu

Principal Investigator:

Vijay Iyer, M.D.

Cuimc/Nyph

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Megha Prasad, M.D.

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Andrea Mignatti, M.D.

OhioHealth

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Arash Arshi, M.D.

614-262-6772joanna.flores-jones@ohiohealth.com

Principal Investigator:

Arash Arshi, M.D.

Oklahoma Heart Hillcrest Medical

Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator:

Kamran Muhammad, M.D.

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Firas Zahr, M.D.

503-494-1775sampsonna@ohsu.edu

Principal Investigator:

Firas Zahr, M.D.

Wellspan York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Rhian Davies, D.O.

717-851-5153hmckinney@wellspan.org

Principal Investigator:

Rhian Davies, D.O.

Prisma Health

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Vince Vismara, M.D.

803-434-3800Suzanne.Smith@PrismaHealth.org

Principal Investigator:

Vince Vismara, M.D.

Baylor Scott & White The Heart Hospital

Recruiting

Plano, Texas, United States, 75093

Contacts

Karim Al-Azizi, M.D.

469-800-6300Osniel.GonzalezRamos@BSWHealth.org

Principal Investigator:

Karim Al-Azizi, M.D.

More Information

Sponsor

Supira Medical

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Percutaneous ventricular assist device
  • Supira System
  • Mechanical Circulatory Support
  • US Pivotal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Supira Medical on 2026-08-26.