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

May 26, 2026 updated by: Supira Medical

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.

Study Type

Interventional

Enrollment (Estimated)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chris DeMorrett
  • Phone Number: 669-330-0883

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Contact:
          • Garrett Wong, M.D.
        • Principal Investigator:
          • Garrett Wong, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
          • David Kandzari, M.D.
        • Principal Investigator:
          • David Kandzari, M.D.
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Henry Ford Health / St. John Hospital
        • Contact:
          • Amir Kaki, M.D.
        • Principal Investigator:
          • Amir Kaki, M.D.
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56362
        • Recruiting
        • CentraCare
        • Contact:
          • Stephen Kidd, M.D.
        • Principal Investigator:
          • Stephen Kidd, M.D.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University in St. Louis
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Cuimc/Nyph
        • Contact:
          • Megha Prasad, M.D.
        • Principal Investigator:
          • Megha Prasad, M.D.
        • Sub-Investigator:
          • Ajay Kirtane, M.D.
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Andrea Mignatti, M.D.
        • Principal Investigator:
          • Andrea Mignatti, M.D.
    • Ohio
      • Columbus, Ohio, United States, 43214
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Hillcrest Medical
        • Principal Investigator:
          • Kamran Muhammad, M.D.
        • Contact:
          • Kamran Muhammad, M.D.
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Not yet recruiting
        • Wellspan York Hospital
        • Contact:
    • Texas
      • Plano, Texas, United States, 75093
        • Not yet recruiting
        • Baylor Scott & White The Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supira System
Subjects receiving the Supira System
Device: 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.
Active Comparator: Impella
Subjects receiving the Impella
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Safety and Efficacy Outcomes
Time Frame: 30 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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measures
Time Frame: 30 and 90 days

Individual rates of the following outcomes:

  • All-cause death
  • MI
  • Stroke or TIA
  • Major bleeding
  • Major access site-related vascular complications
  • AKI
  • Unplanned repeat vascularization
  • Cardiovascular re-hospitalization
  • Ventricular arrhythmia requiring cardioversion
  • Major cardiac structural complications
  • Major Hemolysis
30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supira Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-10004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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