Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

Last updated: April 3, 2024
Sponsor: Cardiovascular Research Foundation, New York
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Occlusions

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT05949515
RESCU
  • Ages > 18
  • All Genders

Study Summary

The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Data from all patients who received SSO2 treatment and have completed a minimum of 3months follow up will be collected at each participating center; there are no otherexclusion criteria aside from date of treatment.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 403
Study Start date:
July 31, 2023
Estimated Completion Date:
March 31, 2024

Study Description

The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter").

This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Connect with a study center

  • Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • NCH Healthcare System

    Naples, Florida 34102
    United States

    Site Not Available

  • Oakwood Healthcare, Inc

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Northwell Health, Inc

    Great Neck, New York 11021
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Avita Health

    Galion, Ohio 44833
    United States

    Site Not Available

  • St. Mary's Medical Center

    Huntington, West Virginia 25702
    United States

    Site Not Available

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