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

NCT04743245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2026-04-14

No results posted yet for this study

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

Conditions

  • Acute Myocardial Infarction
  • STEMI

Interventions

DEVICE

TherOx DownStream System

SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)

DEVICE

PCI

Standard Care of PCI

Sponsors & Collaborators

  • TherOx

    lead INDUSTRY

Principal Investigators

  • James Blankenship, MD · University of New Mexico

  • Gregg Stone, MD · MOUNT SINAI HOSPITAL

  • Amir S Lotfi, MD · Baystate Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04743245 on ClinicalTrials.gov