Status:
ACTIVE_NOT_RECRUITING
The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack
Lead Sponsor:
Fundacio Privada Mon Clinic Barcelona
Collaborating Sponsors:
Zoll Medical Corporation
Conditions:
Anterior STEMI
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study tests whether adding supersaturated oxygen (SSO₂) therapy to standard stent treatment can improve heart recovery after a major heart attack (anterior STEMI). Adults treated within 6 hours of...
Detailed Description
This is an investigator-initiated, post-market clinical investigation, interventional, prospective, randomized, controlled, open-label, monocenter study, in subjects with anterior STEMI with two paral...
Eligibility Criteria
Inclusion
- The subject must be ≥ 18 years of age
- 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.
- Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 6 hours.
- Provision of informed consent by patient
- Culprit lesion in proximal or mid LAD.
- Pre-PCI TIMI flow 0-1.
- The patient is eligible for primary PCI.
- Successful PCI of a proximal or mid LAD lesion with commercially available coronary stents and achievement of TIMI 2 or 3 flow
- Expected ability to place the catheter in the left main coronary ostium to deliver SSO2 therapy with stable and coaxial alignment.
Exclusion
- Previous MI, PCI or CABG occurred before index procedure.
- Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
- Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
- Known coagulopathy.
- Known ongoing anticoagulant treatment.
- Known large pericardial effusion or cardiac tamponade.
- Known allergies to polyurethanes, PET or stainless steel.
- Unconscious at presentation.
- Need for circulatory support.
- Need for invasive mechanical ventilation.
- Need for temporal intravenous pacemaker.
- Cardiopulmonary resuscitation (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
- Patients confirmed as pregnant.
- Active participation in another drug or device investigational trial.
- Known contraindication for adenosine administration (severe asthma, complicated AV block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
- Patient not suitable for femoral access.
- Patients with mechanical complications of STEMI.
- Known epicardial stenosis on LAD lesion after stent placement that restricts flow with the SSO2 delivery catheter in place.
- Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated
- Presence of an intra-aortic balloon pump.
- Presence of a post-intervention non-stented coronary dissection or perforation.
- Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
- Cardiogenic shock.
- Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
- Hemoglobin \< 10 g/dL.
- Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07000266
Start Date
May 23 2025
End Date
December 31 2027
Last Update
June 2 2025
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036