TherOx is currently enrolling patients in the IntraCoronary Hyperoxemic SuperSaturated Oxygen Therapy (IC-HOT) clinical trial. This is a multi-center evaluation of the delivery of IntraCoronary Hyperoxemic SuperSaturated Oxygen Therapy for 60 minutes in anterior acute myocardial infarction patients with successful reperfusion (via PCI) ≤ six hours after symptom onset. This study is designed to confirm the results of the Optimized SSO2 (OSSO2) IDE pilot study in a larger 100-patient IDE study of the target patient population.
Optimized SSO2 Therapy
TherOx made improvements upon the SSO2 Therapy delivery platform, delivering the infusion more proximally and away from the PCI injury zone, as shown in a side-by-side comparison of the original approach and the optimized approach.
The delivery point for the infusion changed from the sub-selective coronary artery to a proximal position in the left main coronary artery (LMCA). The infusion may be performed through a qualified SSO2 delivery catheter (i.e., a 5F angiographic catheter qualified through testing for this procedure) in the LMCA, eliminating the need for the extra infusion catheter. By moving the infusion point proximally, patient safety is improved due to elimination of mechanical manipulation near the PCI injury zone. In addition, the infusion is performed in a higher flow main artery, reducing concerns about restricting flow in part of the sub-selective target vessel. Advantages in effectiveness may be observed because flow of superoxygenated blood will be directed to the entire left coronary system (including collateral vessels) instead of just the target vessel. Finally, the infusion time has been reduced from 90 minutes to 60 minutes, while infusing the same amount of total oxygen.
OSSO2 Pilot Study
TherOx conducted the Optimized SSO2 (OSSO2) IDE pilot study in 20 patients enrolled at 3 US hospital centers to confirm the viability of the modified infusion. The target population was the same as previous IDE studies – qualifying anterior AMI patients treated with PCI within six hours of symptom onset. Primary data collection was performed through 30 days, including adverse event reporting and cardiac MRI imaging. Results showed a low complication rate – one patient (5%; 1/20) experienced a 30-day MACE event (stent thrombosis and reinfarction). No patient deaths were observed and all patients were followed through 30 days. MRI results were obtained in 90% (18/20) of patients at 30 days (2 were not obtainable due to patient claustrophobia). The median [interquartile range] infarct size at 30 days was 9.6% [2.1%, 14.5%].
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.