A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 T… (NCT05156996) | Clinical Trial Compass
TerminatedNot Applicable
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System
Stopped: Transitioning to a new Registry trial
United States6 participantsStarted 2022-12-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Men or women aged 18 years or older.
âś“. Presentation with anterior acute ST-elevation myocardial infarction (\> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
âś“. 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).
âś“. 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.
âś“. 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).
âś“. Patient and his/her physician agree to all required follow-up procedures and visits.
Exclusion criteria
âś•. Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
âś•. Presence of an intra-aortic balloon pump.
âś•. Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
âś•. Presence of a post-intervention non-stented coronary dissection or perforation.
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What they're measuring
1
Measures (hierarchical) at 12-months post-procedure include rates of:
Timeframe: 12 months post-procedure
2
Measures (hierarchical) at 12-months post-procedure include rates of:
Timeframe: 12 months post-procedure
3
Measures (hierarchical) at 12-months post-procedure include rates of:
Timeframe: 12 months post-procedure
4
Measures (hierarchical) at 12-months post-procedure include rates of:
Timeframe: 12 months post-procedure
5
Measures (hierarchical) at 12-months post-procedure include rates of: