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

GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria:

Pre-PCI:

• The subject must be ≥18 and ≤80 years of age.
• AMI must be anterior.
• Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration.
• Signed Informed Consent.
• Subject agrees to all required follow-up procedures and visits.
• Negative pregnancy test for women of childbearing potential.

ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:

• PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD.
• The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery.
• Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
• Successful angioplasty 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.
• Planned revascularization of a non-target lesion is allowed.

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.
• Thrombolytic therapy administered for this STEMI.
• An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents 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 angioplasty or stenting in the LAD.
• Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation.
• Any contraindication to undergo MRI imaging.
• Impaired renal function 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.
• 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 a may cause non-compliance with the protocol.
• Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.
• Current use of warfarin, dabigatran, or factor Xa inhibitors.
• Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia.
• Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.
• Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study.
• Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period.
• Previous enrollment in this study.

ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:

• Inability to achieve a stable coaxial position in the left main coronary artery with the catheter.
• Treatment during the index procedure of any lesion in the left main, LCX, and/or RCA.
• Coronary anatomy such that coronary artery bypass graft surgery is indicated within 30 days.
• Post-index procedure planned intervention within 30 days.
• Anatomic features are present which are highly unfavorable for PCI.
• Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.
• Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm.
• 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 or for which PCI will be required before the MRI study.
• Presence of a non-stented coronary dissection upon completion of the PCI procedure.