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

Stopped early · Not applicable

Conditions studied: Acute Myocardial Infarction, STEMI

In brief

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

Key facts

Study ID: NCT04743245
Run by: TherOx
People needed: 17
Starts: 2022-08-02
Expected to finish: 2026-04-10
Last updated by the study team: 2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Pre-PCI:
The subject must be ≥18 years of age.
AMI must be anterior (ST-segment elevation >1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).
The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
Subject and his/her physician agree to all required follow-up procedures and visits.
ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent and has undergone cardiac catheterization and PCI if indicated:
Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion) in the LAD.
The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).
Successful angioplasty is completed <6 hrs from symptom onset, as documented by 30% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment.
Systemic arterial pO2 greater than or equal to 80 mmHg as measured by arterial blood gas (may be repeated if low after supplemental O2 administration).

You may not qualify if…

Patients will be excluded if ANY of the following conditions apply:
GENERAL EXCLUSION CRITERIA
Pre-PCI:
Prior CABG surgery.
Prior myocardial infarction or known prior systolic dysfunction (e.g. due to cardiomyopathy); this criterion does not include left ventricular dysfunction induced by the acute MI.
An elective surgical procedure is planned during the first 30 days post-enrollment.
Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.
Contraindication to MRI imaging, including any of the following:
Non-MRI compatible cardiac pacemaker or implantable defibrillator;
Non-MRI compatible aneurysm clip or other metallic implants;
Neural Stimulator (i.e., TENS unit);
Any implanted or magnetically activated device (insulin pump);
Any type of non-MRI compatible ear implant;
Metal shavings in the orbits;
Any indwelling metallic foreign body, shrapnel, or bullet;
Any condition contraindicating MRI, including claustrophobia;
Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
Known hypersensitivity or contraindication to gadolinium contrast.
Known impaired renal function (creatinine clearance <30 ml/min/1.73 m2 by the MDRD formula) or on dialysis.
Known platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a known Hgb <10 g/dL.
Subject has active bleeding or a history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary.
History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.

Where it is running

Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.