A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System
NCT ID: NCT05156996
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
6 participants
OBSERVATIONAL
2022-12-04
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment Group
Supersaturated O2 Therapy of the Therox Downstream System®
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.
Control Group
PCI alone
Percutaneous Coronary Intervention for treatment of acute MI
Interventions
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Supersaturated O2 Therapy of the Therox Downstream System®
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.
PCI alone
Percutaneous Coronary Intervention for treatment of acute MI
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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TherOx
INDUSTRY
Responsible Party
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Locations
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Charleston Area Medical Center
Charleston, West Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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Other Identifiers
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REAL SSO2
Identifier Type: -
Identifier Source: org_study_id
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