A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System

Study Overview
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Brief Summary
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The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.

Official Title
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A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction

Conditions
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Anterior Acute Myocardial Infarction (AMI)

Intervention / Treatment
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* Device: Supersaturated O2 Therapy of the Therox Downstream System®
* Procedure: PCI alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18 years or older. Presentation with anterior acute ST-elevation myocardial infarction (> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4). The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated). Successful angioplasty within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock. The patient or their 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). Patient and his/her physician agree to all required follow-up procedures and visits. Exclusion Criteria: Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated. Presence of an intra-aortic balloon pump. Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place Presence of a post-intervention non-stented coronary dissection or perforation. Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy. Pregnant or nursing women. Cardiogenic shock. Patients contraindicated for anticoagulation therapy. Patients with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture). Hemoglobin < 10 g/dL. Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure. Patients with active COVID-19 infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Group<br> | Device: Supersaturated O2 Therapy of the Therox Downstream System®<br>* SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.<br>|
| Control Group<br> | Procedure: PCI alone<br>* Percutaneous Coronary Intervention for treatment of acute MI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures (hierarchical) at 12-months post-procedure include rates of: | Rate of Cardiovascular Death | 12 months post-procedure | 
| Measures (hierarchical) at 12-months post-procedure include rates of: | Rate of Heart Transplant or LVAD | 12 months post-procedure | 
| Measures (hierarchical) at 12-months post-procedure include rates of: | Rate of ICD/CRT device implanted | 12 months post-procedure | 
| Measures (hierarchical) at 12-months post-procedure include rates of: | Rate of Rehospitalization for heart failure between discharge and 12 months post-procedure | 12 months post-procedure | 
| Measures (hierarchical) at 12-months post-procedure include rates of: | Rate of KCCQ-OS score at 1 year | 12 months post-procedure |