Anterior STEMINCT07000266
The RECOVERY Study: Using Supersaturated Oxygen Therapy To Treat Small Vessel Blockages After a Heart Attack
A study testing Percutaneous Coronary Intervention (PCI), Diagnostic Imaging and Device Treatment in people with Anterior STEMI, run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
Trial 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 symptoms will be randomly assigned to receive either standard care or standard care plus SSO₂. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior STEMI
- What is being tested?
- Percutaneous Coronary Intervention (PCI), Diagnostic Imaging and Device Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovering Coronary Microvascular Obstruction With Supersaturated Oxygen Therapy in ST-segment Elevation Myocardial Infarction (STEMI) Patients: The RECOVERY Study
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 symptoms will be randomly assigned to receive either standard care or standard care plus SSO₂. The goal is to see if SSO₂ reduces damage to small heart vessels. Heart function will be checked immediately, after one hour, and again at six months. Follow-up visits will track recovery for up to a year.
Read the 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 parallel arms comparing the efficacy of SSO2 with standard PCI and standard PCI alone on reduction of microvascular resistances (Rµ)
Patients will be ≥ 18 years old and diagnosed with a first anterior STEMI requiring stent placement, symptoms duration of ≤ 6 hours and culprit lesion in the left anterior descending (LAD) artery with a TIMI (Thrombolysis In Myocardial Infarction) flow 0 or 1 without collateral circulation.
Patients who provide informed consent will be treated with primary PCI with stenting. Once the coronary blood flow is re-established, and after general and angiographic inclusion and exclusion criteria are confirmed, patients will be randomized and enrolled in the study.
A total number of 20 patients will be randomized (1:1) to SSO2 plus PCI arm or standard PCI control arm. Once randomized, SSO2 arm patients will receive SSO2 therapy inside the catheterization laboratory, meanwhile patients randomized in the standard arm will not receive further treatment beyond standard of care.
For both arms, coronary invasive measurements will be performed immediately and 60 minutes after coronary blood flow restoration and then at 6 months timepoint. Baseline clinical and procedural variables will be collected. There will be a clinical follow-up at 30 days ± 7 days, 6 months ± 1 month and 1 year ± 1 month after index event.
- Conditions
- Anterior STEMI
- Being tested
- Percutaneous Coronary Intervention (PCI), Diagnostic Imaging, Device Treatment, Follow-up at 30 days, Follow-up at 60 days
- Keywords
- TherOx DownStream System, Microvascular obstruction, Supersaturated oxygen therapy, SSO2, Percutaneous Coronary Intervention (PCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Standard PCI intervention
Diagnostic ImagingDiagnostic test
Cardiac Magnetic Ressonance (CMR) and hospital discharge
Device TreatmentDevice
SSO2 therapy
Follow-up at 30 daysProcedure or surgery
Remote (phone) follow-up at 30 days
Follow-up at 60 daysProcedure or surgery
In person follow-up at 60 days
Follow-up at 12 monthsProcedure or surgery
Remote (phone) follow-up at 12 months
| Study group | Role | What they receive |
|---|---|---|
| Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy | Experimental | Treatment group Receives: Procedure: Percutaneous Coronary Intervention (PCI); Diagnostic Test: Diagnostic Imaging; Device: Device Treatment; Procedure: Follow-up at 30 days; Procedure: Follow-up at 60 days; Procedure: Follow-up at 12 months |
| Standard Percutaneous Coronary Intervention (PCI) | Experimental | Control group Receives: Procedure: Percutaneous Coronary Intervention (PCI); Diagnostic Test: Diagnostic Imaging; Procedure: Follow-up at 30 days; Procedure: Follow-up at 60 days; Procedure: Follow-up at 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of SSO2 on microvascular resistances (Rµ)
Superiority in % of patients without microvascular dysfunction (defined as microvascular resistance >500 WU) of SSO2 arm versus standard of care (90% of patients with microvascular dysfunction in the control arm vs. 30% in the SSO2 arm)
Measured: 60 minutes after primary PCI
Secondary outcomes (8)
Effect of SSO2 on absolute coronary flow (Q)
Absolute coronary flow (Q): difference in Q, between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Measured: At 60 minutes and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Microvascular resistances (Rµ): difference in (Rµ) between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Measured: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Index of microvascular resistance (IMR): difference in IMR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Measured: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the coronary flow reserve (CFR)
Coronary flow reserve (CFR): difference in CFR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Measured: Within 5 minutes after primary PCI, at 60 minutes after PCI and at 6 months after primary PCI
Effect of SSO2 on the microvascular resistance reserve (MRR)
Microvascular resistance reserve (MRR): difference in MRR between the SSO2 arm and the standard PCI control arm, evaluated with invasive coronary measurement.
Measured: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on infarct size and microvascular obstruction at CMR
Quantification of infarct size as a percentage of left ventricular mass using late gadolinium enhancement (LGE) and assessment of microvascular obstruction (MVO) presence and extent.
Measured: At CMR 3-5 days after primary PCI
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Time from randomization to the first occurrence of any event in the predefined MACE composite per patient.
Measured: During treatment, during follow-up at 30 days, 60 days and 12 months follow-ups
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Per-patient rate of composite MACE events (first and subsequent)
Measured: At at 30 days, 6 months and 1 year follow-ups after index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start23 May 2025
- Primary completion16 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an investigator-initiated, post-market clinical investigation, interventional, prospective, randomized, controlled, open-label, monocenter study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Zoll Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000266
- Sponsor's protocol ID
- 24-ZOL-501
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering Coronary Microvascular Obstruction With Supersaturated Oxygen Therapy in ST-segment Elevation Myocardial Infarction (STEMI) Patients: The RECOVERY Study
- ClinicalTrials.gov ID
- NCT07000266
- Acronym / sponsor ID
- 24-ZOL-501
- Conditions
- Anterior STEMI
- Keywords
- TherOx DownStream System, Microvascular obstruction, Supersaturated oxygen therapy, SSO2, Percutaneous Coronary Intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacio Privada Mon Clinic BarcelonaUniversity, hospital or other
- Collaborators
- Zoll Medical Corporation
- Study start
- 23 May 2025 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 symptoms will be randomly assigned to receive either standard care or standard care plus SSO₂. The goal is to see if SSO₂ reduces damage to small heart vessels. Heart function will be checked immediately, after one hour, and again at six months. Follow-up visits will track recovery for up to a year.
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 parallel arms comparing the efficacy of SSO2 with standard PCI and standard PCI alone on reduction of microvascular resistances (Rµ)
Patients will be ≥ 18 years old and diagnosed with a first anterior STEMI requiring stent placement, symptoms duration of ≤ 6 hours and culprit lesion in the left anterior descending (LAD) artery with a TIMI (Thrombolysis In Myocardial Infarction) flow 0 or 1 without collateral circulation.
Patients who provide informed consent will be treated with primary PCI with stenting. Once the coronary blood flow is re-established, and after general and angiographic inclusion and exclusion criteria are confirmed, patients will be randomized and enrolled in the study.
A total number of 20 patients will be randomized (1:1) to SSO2 plus PCI arm or standard PCI control arm. Once randomized, SSO2 arm patients will receive SSO2 therapy inside the catheterization laboratory, meanwhile patients randomized in the standard arm will not receive further treatment beyond standard of care.
For both arms, coronary invasive measurements will be performed immediately and 60 minutes after coronary blood flow restoration and then at 6 months timepoint. Baseline clinical and procedural variables will be collected. There will be a clinical follow-up at 30 days ± 7 days, 6 months ± 1 month and 1 year ± 1 month after index event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an investigator-initiated, post-market clinical investigation, interventional, prospective, randomized, controlled, open-label, monocenter study
| Arm | Type | Receives |
|---|---|---|
| Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy | Experimental | Procedure: Percutaneous Coronary Intervention (PCI), Diagnostic Test: Diagnostic Imaging, Device: Device Treatment, Procedure: Follow-up at 30 days, Procedure: Follow-up at 60 days, Procedure: Follow-up at 12 monthsTreatment group |
| Standard Percutaneous Coronary Intervention (PCI) | Experimental | Procedure: Percutaneous Coronary Intervention (PCI), Diagnostic Test: Diagnostic Imaging, Procedure: Follow-up at 30 days, Procedure: Follow-up at 60 days, Procedure: Follow-up at 12 monthsControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Standard PCI intervention | Procedure or surgery | Standard Percutaneous Coronary Intervention (PCI), Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
| Diagnostic ImagingCardiac Magnetic Ressonance (CMR) and hospital discharge | Diagnostic test | Standard Percutaneous Coronary Intervention (PCI), Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
| Device TreatmentSSO2 therapy | Device | Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
| Follow-up at 30 daysRemote (phone) follow-up at 30 days | Procedure or surgery | Standard Percutaneous Coronary Intervention (PCI), Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
| Follow-up at 60 daysIn person follow-up at 60 days | Procedure or surgery | Standard Percutaneous Coronary Intervention (PCI), Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
| Follow-up at 12 monthsRemote (phone) follow-up at 12 months | Procedure or surgery | Standard Percutaneous Coronary Intervention (PCI), Standard Percutaneous Coronary Intervention (PCI) plus supersaturated oxygen (SSO2) therapy |
Primary outcome
Effect of SSO2 on microvascular resistances (Rµ)
Time frame: 60 minutes after primary PCI
Superiority in % of patients without microvascular dysfunction (defined as microvascular resistance >500 WU) of SSO2 arm versus standard of care (90% of patients with microvascular dysfunction in the control arm vs. 30% in the SSO2 arm)
8 secondary outcomes
Effect of SSO2 on absolute coronary flow (Q)
Time frame: At 60 minutes and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Time frame: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the index of microvascular resistance (IMR)
Time frame: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on the coronary flow reserve (CFR)
Time frame: Within 5 minutes after primary PCI, at 60 minutes after PCI and at 6 months after primary PCI
Effect of SSO2 on the microvascular resistance reserve (MRR)
Time frame: Within 5 minutes after primary PCI, at 60 minutes after primary PCI and at 6 months after primary PCI
Effect of SSO2 on infarct size and microvascular obstruction at CMR
Time frame: At CMR 3-5 days after primary PCI
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Time frame: During treatment, during follow-up at 30 days, 60 days and 12 months follow-ups
Risk of predefined major cardiovascular adverse events (MACE) during treatment and follow-up
Time frame: At at 30 days, 6 months and 1 year follow-ups after index PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention (PCI), Diagnostic Imaging and Device Treatment in people with Anterior STEMI, run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of SSO2 on microvascular resistances (Rµ) (time frame: 60 minutes after primary PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.