Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)

Not Applicable

Completed

Brief Summary: The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

Detailed Description: A Multi-Center, Consecutively Enrolled Single-Arm Study to confirm the safety and effectiveness of the delivery of supersaturated oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA) with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of qualified patients presenting with anterior acute myocardial infarction in whom reperfusion with PCI is successful within six hours after symptom onset.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SSO2 Therapy	SSO2 Therapy	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

Primary Outcome Measures

Name	Time	Method
Rate of Net Adverse Clinical Events (NACE)	30-Day	Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.

Secondary Outcome Measures

Name	Time	Method
Target Lesion Failure	1 year	Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
Rate of Target Lesion Failure	30 days	Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
Median Infarct Size by Cardiac MRI	30 days	Measurement of the % left ventricle (LV) necrosis
Microvascular Obstruction by Cardiac MRI	4 days post-procedure	Measurement of the % left ventricle (LV) showing microvascular obstruction
Rate of Net Adverse Clinical Events (NACE)	1 year	Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding. This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two or more event types they are only counted once in the overall NACE rate.

Locations (15): Henry Ford Medical Center
🇺🇸
Detroit, Michigan, United States
St. John Hospital & Medical Center
🇺🇸
Detroit, Michigan, United States
Heart Center, Inc.
🇺🇸
Huntsville, Alabama, United States
Scripps Hospital
🇺🇸
La Jolla, California, United States
Danbury Hospital
🇺🇸
Danbury, Connecticut, United States
Alexian Brothers Heart & Vascular Institute
🇺🇸
Elk Grove Village, Illinois, United States
Baystate Medical Center
🇺🇸
Springfield, Massachusetts, United States
WakeMed Heart Center
🇺🇸
Raleigh, North Carolina, United States
Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Lehigh Valley Hospital
🇺🇸
Allentown, Pennsylvania, United States
Providence-Providence Park Hospital
🇺🇸
Southfield, Michigan, United States
Holy Spirit Cardiology
🇺🇸
Camp Hill, Pennsylvania, United States
The Miriam Hospital/Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States