Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05949515

Acronym

RESCU

Enrollment

403

Registered

2023-07-18

Start date

2023-07-31

Completion date

2024-03-31

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST Segment Elevation Myocardial Infarction

Brief 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).

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change of Left Ventricular Ejection Fraction	Baseline to 3 months	Between group comparison
Rate of Cardiovascular related Hospitalizations	Through study completion, an average of 1 year	Between group comparison

Countries

United States

Outcome results