Clinical trial NCT05156996: A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System
Official title: A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anterior Acute Myocardial Infarction (AMI)
Lead sponsor: TherOx
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measures (hierarchical) at 12-months post-procedure include rates of:
timeFrame: 12 months post-procedure
measure: Measures (hierarchical) at 12-months post-procedure include rates of:
timeFrame: 12 months post-procedure
measure: Measures (hierarchical) at 12-months post-procedure include rates of:
timeFrame: 12 months post-procedure
measure: Measures (hierarchical) at 12-months post-procedure include rates of:
timeFrame: 12 months post-procedure
measure: Measures (hierarchical) at 12-months post-procedure include rates of:
timeFrame: 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
References: