NCT05949515

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
• Phase: —
• Study type: Observational
• Enrollment: 403 (actual)
• Sponsor: Cardiovascular Research Foundation, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Acute ST Segment Elevation Myocardial Infarction

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-02-28
• Completion: 2024-03-31
• First posted: 2023-07-18
• Last updated: 2024-04-04

Locations

8 sites across 1 country: United States