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Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility — RESCU  

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility (RESCU). An Analysis of Clinical Outcomes and Left Ventricular Recovery of STEMI Patients Treated With SSO2 Therapy After Primary Percutaneous Coronary Intervention (PPCI)

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05949515
Study type Observational
Source Cardiovascular Research Foundation, New York
Contact
Status Completed
Phase
Start date July 31, 2023
Completion date March 31, 2024
View Details
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