Actively Recruiting
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
Led by TherOx · Updated on 2026-04-14
434
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy
CONDITIONS
Official Title
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Anterior acute myocardial infarction with ST-segment elevation >1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block
- Informed consent provided by the subject or legally authorized representative
- Agreement to all required follow-up procedures and visits
- PCI indicated for revascularization of culprit lesion(s) in the proximal and/or mid left anterior descending (LAD) artery using a coronary stent
- Successful angioplasty completed within 6 hours from symptom onset with residual stenosis ≤30% and TIMI 2 or 3 flow without major complications
- Ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system with stable alignment
- Systemic arterial pO2 ≥80 mmHg measured by arterial blood gas
You will not qualify if you...
- Prior coronary artery bypass graft (CABG) surgery
- Prior myocardial infarction or known prior systolic dysfunction excluding acute MI-induced dysfunction
- Elective surgery planned within 30 days post-enrollment
- Previous coronary stent implantation with stent thrombosis causing current anterior AMI
- Previous angioplasty or stenting in the left anterior descending artery
- Contraindications to MRI including non-compatible implants, devices, metal fragments, claustrophobia, inability to hold breath >15 seconds, or gadolinium contrast hypersensitivity
- Impaired renal function (creatinine clearance <30 ml/min/1.73 m2) or dialysis
- Platelet count <100,000 or >700,000 cells/mm3, or hemoglobin <10 g/dL
- Active bleeding or history of bleeding disorders or refusal of blood transfusions
- History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
- Stroke or transient ischemic attack within past 6 months or permanent neurological defects
- Recent gastrointestinal or genitourinary bleeding or major surgery within specified time frames
- Organ transplant recipient or awaiting transplant
- Medical illnesses or substance abuse impacting compliance or life expectancy less than one year
- Hypersensitivity or contraindication to study medications or contrast not manageable by premedication
- Cardiogenic shock, need for hemodynamic support, prolonged resuscitation, or severe arrhythmias prior to PCI completion
- Severe valvular heart disease, pericardial disease, or cardiomyopathy
- Vulnerable populations or conditions interfering with study participation or follow-up
- Current participation in other investigational device or drug studies without primary endpoint reached
- Previous enrollment in this study
- Current or recent COVID-19 infection unless fully recovered and asymptomatic for required periods
- Treatment of lesions in left main, LCX, or RCA during index procedure
- Planned intervention within 7 days post-index procedure
- Anterior MI due to thrombosis near previously implanted stent
- Severe mitral regurgitation, ventricular septal defect, pseudoaneurysm, aortic dissection, or mechanical MI complications
- Left main coronary artery stenosis >20%
- Untreated LAD or diagonal branch lesion with >50% stenosis and vessel diameter >2.0 mm
- Presence of non-stented coronary dissection with NHLBI grade >B after PCI procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
Research Team
J
Jeffrey Creech, PhD
CONTACT
S
Shailaja Lakma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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