Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack

NCT01630707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-22

Study results available
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Summary

The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA). The therapy will be delivered with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of patients presenting with an anterior acute myocardial infarction (heart attack) ≤ six hours after symptom onset with successful reperfusion (via PCI).

Conditions

  • Anterior Wall Acute Myocardial Infarction

Interventions

DEVICE

SuperSaturated Oxygen (SS02) Therapy

Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter

Sponsors & Collaborators

  • TherOx

    lead INDUSTRY

Principal Investigators

  • Gregg W Stone, M.D. · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-09-30
Completion
2014-08-31
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 NCT01630707 on ClinicalTrials.gov