Trial Outcomes & Findings for Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack (NCT NCT01630707)

Results Overview

Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Procedure

Results posted on

2026-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Optimized SSO2 Therapy SuperSaturated Oxygen (SS02) 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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optimized SSO2 Therapy n=20 Participants SuperSaturated Oxygen (SS02) 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
Age, Continuous	55.0 years STANDARD_DEVIATION 11.9 • n=2 Participants
Sex: Female, Male Female	2 Participants n=2 Participants
Sex: Female, Male Male	18 Participants n=2 Participants
Region of Enrollment United States	20 participants n=2 Participants
Location of infarct lesion Proximal LAD	7 participants n=2 Participants
Location of infarct lesion Mid-LAD	13 participants n=2 Participants
Door-to-balloon time	63 minutes n=2 Participants
Symptom onset-to-balloon time	163 minutes n=2 Participants

PRIMARY outcome

Timeframe: Procedure

Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events

Outcome measures

Outcome measures
Measure	Optimized SSO2 Therapy n=20 Participants SuperSaturated Oxygen (SS02) 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
The Feasibility of Intracoronary Infusion of SSO2 Therapy	20 participants

SECONDARY outcome

Timeframe: 3 to 5 days post-procedure

Population: Cardiac MRI was attempted in all 20 subjects, but evaluable data were not available for every subject at every time point. Missing or non-evaluable scans could reflect scans not reported, technical or core-lab issues, or patient inability to tolerate the procedure (for example, claustrophobia). The specific cause per subject is not known. The analysis includes all subjects with evaluable data at each time point.

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.

Outcome measures

Outcome measures
Measure	Optimized SSO2 Therapy n=15 Participants SuperSaturated Oxygen (SS02) 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
Median Myocardial Salvage Index	49.9 percentage Interval 39.7 to 80.6

SECONDARY outcome

Timeframe: 3 to 5 days post-procedure

Population: Cardiac MRI was attempted in all 20 subjects, but evaluable data were not available for every subject at every time point. Missing or non-evaluable scans could reflect scans not reported, technical or core-lab issues, or patient inability to tolerate the procedure (for example, claustrophobia). The specific cause per subject is not known. The analysis includes all subjects with evaluable data at each time point.

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.