A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System (REAL)

TherOx

Status: Terminated

Conditions: Anterior Acute Myocardial Infarction (AMI)

Treatments: Procedure: PCI alone; Device: Supersaturated O2 Therapy of the Therox Downstream System®

Study type: Observational

Funder types: Industry

Identifiers

NCT05156996

REAL SSO2

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women aged 18 years or older.
2. Presentation with anterior acute ST-elevation myocardial infarction (> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
3. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated).
4. Successful angioplasty within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
5. The patient or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
6. Patient and his/her physician agree to all required follow-up procedures and visits.

Exclusion criteria

1. Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
2. Presence of an intra-aortic balloon pump.
3. Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
4. Presence of a post-intervention non-stented coronary dissection or perforation.
5. Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
6. Pregnant or nursing women.
7. Cardiogenic shock.
8. Patients contraindicated for anticoagulation therapy.
9. Patients with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
10. Hemoglobin < 10 g/dL.
11. Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
12. Patients with active COVID-19 infection.

Trial design

6 participants in 2 patient groups

Treatment Group

Treatment:

Device: Supersaturated O2 Therapy of the Therox Downstream System®

Control Group

Treatment:

Procedure: PCI alone