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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04743245
Study type Interventional
Source TherOx
Contact Jeffrey Creech, PhD
Phone 3233096949
Email jcreech@zoll.com
Status Recruiting
Phase N/A
Start date August 2, 2022
Completion date April 30, 2026
View Details
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