Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT07000266
Eligibility Criteria:
Inclusion Criteria:
1. The subject must be ≥ 18 years of age
2. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
3. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 6 hours.
4. Provision of informed consent by patient
5. Culprit lesion in proximal or mid LAD.
6. Pre-PCI TIMI flow 0-1.
7. The patient is eligible for primary PCI.
8. Successful PCI of a proximal or mid LAD lesion with commercially available coronary stents and achievement of TIMI 2 or 3 flow
9. Expected ability to place the catheter in the left main coronary ostium to deliver SSO2 therapy with stable and coaxial alignment.
Exclusion Criteria:
1. Previous MI, PCI or CABG occurred before index procedure.
2. Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
3. Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
4. Known coagulopathy.
5. Known ongoing anticoagulant treatment.
6. Known large pericardial effusion or cardiac tamponade.
7. Known allergies to polyurethanes, PET or stainless steel.
8. Unconscious at presentation.
9. Need for circulatory support.
10. Need for invasive mechanical ventilation.
11. Need for temporal intravenous pacemaker.
12. Cardiopulmonary resuscitation (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
13. Patients confirmed as pregnant.
14. Active participation in another drug or device investigational trial.
15. Known contraindication for adenosine administration (severe asthma, complicated AV block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
16. Patient not suitable for femoral access.
17. Patients with mechanical complications of STEMI.
18. Known epicardial stenosis on LAD lesion after stent placement that restricts flow with the SSO2 delivery catheter in place.
19. Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated
20. Presence of an intra-aortic balloon pump.
21. Presence of a post-intervention non-stented coronary dissection or perforation.
22. Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
23. Cardiogenic shock.
24. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
25. Hemoglobin \< 10 g/dL.
26. Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07000266
Study Brief:
Protocol Section:
NCT07000266