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Acute Myocardial InfarctionNCT04743245

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

A study testing TherOx DownStream System and PCI in people with Acute Myocardial Infarction and STEMI, run by TherOx at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Myocardial Infarction, STEMI
What is being tested?
TherOx DownStream System and PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
2 Aug 2022to 10 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -
  • 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.
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  • 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).

Who cannot join

  • -
  • 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.
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  • 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.
  • Subject has received any organ transplant or is on a waiting list for any organ transplant.
  • Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the protocol, confound the data interpretation, or is associated with life expectancy of less than one year.
  • Subject has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated.
  • Subjects presenting with or developing in the cath lab prior to completion of the PCI procedure any of the following conditions: cardiogenic shock (SBP <80 mmHg for >30 minutes), or requiring IV pressors or emergent placement of an intra-aortic balloon pump (IABP), Impella, or other hemodynamic support for hypotension treatment, or cardiopulmonary resuscitation for >10 minutes, or ventricular fibrillation or tachycardia requiring cardioversion or defibrillation.
  • Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy.
  • Subject is a member of a vulnerable population or has any significant medical or social condition which in the investigator's opinion may interfere with the subject's participation in the study or ability to comply with follow-up procedures, including MRI (e.g. alcoholism, dementia, lives far from the research center, etc.).
  • Current participation in other investigational device or drug study that has not reached its primary endpoint.
  • Previous enrollment in this study.
  • Subject is currently hospitalized for definite or suspected COVID-19.
  • Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and had returned to his/her prior baseline (pre-COVID) clinical condition.
  • Subject is asymptomatic (never ill) and COVID-19 PCR/antigen or antibody test is positive within the prior 4 weeks unless subject remained asymptomatic for≥4 weeks after the last positive test.
  • ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent and has undergone cardiac catheterization and PCI if indicated:
  • Treatment during the index procedure of any lesion in either the left main, LCX (including the ramus), and/or RCA.
  • Post-index procedure planned intervention within 7 days (i.e., PCI of non-target lesions in any vessel, or CABG). Note: Planned revascularization (PCI or bypass) of a non-target lesion >7 days following the index procedure and after performance of the 2-7day MRI is allowed.
  • Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.
  • Left ventriculography (mandatory before or after PCI, but in all cases before randomization) demonstrates severe mitral regurgitation, a ventricular septal defect, a pseudoaneurysm, aortic dissection or other mechanical complications of MI.
  • Any left main coronary artery stenosis >20%.
  • Any untreated LAD or diagonal branch lesion is present with diameter stenosis > 50% in a vessel with reference vessel diameter > 2.0 mm (visually estimated).
  • Presence of a non-stented coronary dissection with NHLBI grade >B upon completion of the PCI procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

Other trials in United States

About this study

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

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

Read the 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.

Being tested
TherOx DownStream System, PCI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TherOx DownStream SystemDevice

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

  • PCIDevice

    Standard Care of PCI

Study groups in NCT04743245
Study groupRoleWhat they receive
PCI with SSO2 therapyExperimentalAMI subjects treated with SSO2 Therapy following PCI with stenting
Receives: Device: TherOx DownStream System; Device: PCI
anterior AMI patients treated with PCI and stenting within 6 hoursActive comparatorControl group receiving PCI with stenting alone
Receives: Device: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year rate of Net Adverse Clinical Events (NACE)

    The composite NACE endpoint includes a hierarchical total of the following events:

    • Death (all-cause)
    • Reinfarction
    • Target Vessel Revascularization (ischemia-driven)
    • TIMI major or minor bleeding
    • New onset heart failure or re-hospitalization for heart failure
    • Stent thrombosis (ARC definite or probable)

    Measured: 12 months

Secondary outcomes (1)

  1. Difference in infarct size between SSO2 Therapy and standard therapy in patients

    Change from 2-7 days to 6 months in MRI endpoints

    Measured: At 2-7 days and at 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start2 Aug 2022
  3. Primary completion10 Apr 2026
  4. Study completion10 Apr 2026

Why it stopped: Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04743245
Sponsor's protocol ID
AMIHOT III 09 November 2021
Status last verified
Apr 2025
First submitted
25 Jan 2021
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TherOx DownStream System and PCI in people with Acute Myocardial Infarction and STEMI, run by TherOx at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year rate of Net Adverse Clinical Events (NACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04743245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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