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.
Study Type
OBSERVATIONAL
Enrollment
6
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.
Percutaneous Coronary Intervention for treatment of acute MI
Charleston Area Medical Center
Charleston, West Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of Cardiovascular Death
Time frame: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of Heart Transplant or LVAD
Time frame: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of ICD/CRT device implanted
Time frame: 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
Time frame: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of KCCQ-OS score at 1 year
Time frame: 12 months post-procedure
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