The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA). The therapy will be delivered with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of patients presenting with an anterior acute myocardial infarction (heart attack) ≤ six hours after symptom onset with successful reperfusion (via PCI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
Scottsdale Healthcare
Scottsdale, Arizona, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
Providence Hospital and Medical Centers
Southfield, Michigan, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
The Feasibility of Intracoronary Infusion of SSO2 Therapy
Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events
Time frame: Procedure
Median Myocardial Salvage Index
Myocardial Salvage Index by cardiac MRI at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as (1 - infarct mass / area at risk) × 100, with both quantified in grams of left ventricular myocardium. Range 0% (no salvage, entire area at risk infarcted) to 100% (no infarction within the area at risk). Higher values are better.
Time frame: 3 to 5 days post-procedure
Median Infarct Size by Cardiac MRI
Infarct size by cardiac MRI with late gadolinium enhancement at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as infarct mass divided by total left ventricular mass, expressed as a percentage. Range 0% to 100%. Lower values are better.
Time frame: 3 to 5 days post-procedure
Median Infarct Size by Cardiac MRI
Infarct size by cardiac MRI with late gadolinium enhancement at 30 (±7) days post-procedure, read by an independent MRI core laboratory. Calculated as infarct mass divided by total left ventricular mass, expressed as a percentage. Range 0% to 100%. Lower values are better.
Time frame: 30 days post-procedure
MACE - CEC Adjudicated
cardiac death, reinfarction or ischemia-driven TLR
Time frame: 30 days post-procedure
Target Vessel Failure (TVF) - CEC Adjudicated
all-cause death, reinfarction or ischemia-driven TVR
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Time frame: 30 days post-procedure
Cardiac Death - CEC Adjudicated
Time frame: 30 days post-procedure
Vascular Death - CEC Adjudicated
Time frame: 30 days post-procedure
Non-Cardiovascular Death
Time frame: 30 days post-procedure
New-Onset Heart Failure - CEC Adjudicated
Time frame: 30 days post-procedure
Heart Failure Requiring Hospitalization - CEC Adjudicated
Time frame: 30 days post-procedure
Re-Hospitalization for Previous Heart Failure - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction, Spontaneous - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction, STEMI - CEC Adjudicated
Time frame: 30 days post-procedure
Myocardial Infarction, NSTEMI - CEC Adjudicated
Time frame: 30 days post-procedure
Repeat Angiography/Revascularization - CEC Adjudicated
Time frame: 30 days post-procedure
Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated
Time frame: 30 days post-procedure
Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated
Time frame: 30 days post-procedure
Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Time frame: 30 days post-procedure
Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Time frame: 30 days post-procedure
Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Time frame: 30 days post-procedure
Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Time frame: 30 days post-procedure
Neurologic Event (Stroke, TIA) - CEC Adjudicated
Time frame: 30 days post-procedure
Hemorrhagic/Vascular Event - CEC Adjudicated
Time frame: 30 days post-procedure