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

Cardiovascular Research Foundation (CRF)

Status

Completed

Conditions

Acute ST Segment Elevation Myocardial Infarction

Study type

Observational

Funder types

Other

Identifiers

NCT05949515

RESCU

Details and patient eligibility

About

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).

Full 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.

Enrollment

403 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria