TherOx
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
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.
Inclusion Criteria: \- Pre-PCI: 1. The subject must be ≥18 years of age. 2. 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). 3. 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). 4. Subject and his/her physician agree to all required follow-up procedures and visits. ANGIOGRAPHIC INCLUSION CRI…
SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)
Standard Care of PCI
Arctuva estimate
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