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

NCT05156996 | Terminated FDA Device

• 1 other identifier: REAL SSO2
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anterior Acute Myocardial Infarction (AMI)

Outcome Measures

Primary Outcomes (5)

• Measures (hierarchical) at 12-months post-procedure include rates of:

  Rate of Cardiovascular Death

  12 months post-procedure

• Measures (hierarchical) at 12-months post-procedure include rates of:

  Rate of Heart Transplant or LVAD

  12 months post-procedure

• Measures (hierarchical) at 12-months post-procedure include rates of:

  Rate of ICD/CRT device implanted

  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

  12 months post-procedure

• Measures (hierarchical) at 12-months post-procedure include rates of:

  Rate of KCCQ-OS score at 1 year

  12 months post-procedure

Study Arms (2)

Treatment Group

Device: Supersaturated O2 Therapy of the Therox Downstream System®

Control Group

Procedure: PCI alone

Interventions

Supersaturated O2 Therapy of the Therox Downstream System® DEVICE

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.

Treatment Group

PCI alone PROCEDURE

Percutaneous Coronary Intervention for treatment of acute MI

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient who meets the protocol defined eligibility criteria and none of the exclusion criteria at the time of completion of index procedure and who consents to participate.

You may qualify if:

• Men or women aged 18 years or older.
• Presentation with anterior acute ST-elevation myocardial infarction (\> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
• 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).
• 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.
• 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).
• Patient and his/her physician agree to all required follow-up procedures and visits.

You may not qualify if:

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

Sponsors & Collaborators

• TherOx: lead

Study Sites (2)

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 14, 2021
• Study Start: December 4, 2022
• Primary Completion: January 4, 2024
• Study Completion: April 24, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (2)