NCT04743245

Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.

A Post Approval Study to Evaluate the Delivery of Hyperoxemic Super Saturated Oxygen Therapy for 60 Minutes in Anterior AMI Patients Compared to PCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: TherOx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy

Detailed description

This is a prospective, open-label, randomized (1:1) study. Subjects who present with anterior STEMI requiring stent placement in the proximal and/or mid LAD who meet all inclusion and exclusion criteria and provide informed consent will be treated with PCI with stenting, and if successful and uncomplicated then immediately randomized to post-procedure infusion of SSO2 Therapy for a duration of 60 minutes or standard of care.

Conditions

• Acute Myocardial Infarction
• STEMI

Interventions

Type	Name	Description
DEVICE	TherOx DownStream System	SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)
DEVICE	PCI	Standard Care of PCI

Timeline

• Start date: 2022-08-02
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2021-02-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study