AMI HOT III

Full Name

A MULTI-CENTER RANDOMIZED POST-APPROVAL 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 COMPARED TO STANDARD THERAPY

Description

The AMIHOT III Post-Approval study is designed as a prospective, open label, randomized study enrolling 434 patients (40 at LVHN) with qualifying anterior acute myocardial infarction (AMI) treated with successful percutaneous coronary intervention (PCI) with stenting within 6 hours of symptom onset. SSO2 Therapy is an adjunctive cardiac catheterization laboratory initiated procedure with superoxygenated blood delivered via a qualified delivery catheter to the left main coronary artery (LMCA) in a patient with acute myocardial infarction (AMI) after successful percutaneous intervention (PCI) with stenting has been performed.

Purpose

To confirm the safety and effectiveness of SuperSaturated Oxygen Therapy (SSO2 Therapy). SSO2 Therapy is a novel therapy that complements PCI for treating an acute heart attack (acute myocardial infarction). It is designed to restore microvascular blood flow and reduce damage to the heart muscle to improve overall heart function. This study will compare this new SSO2 Therapy adjunctively with percutaneous coronary intervention (PCI) vs. standard of care, PCI alone.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to: