Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
NCT ID: NCT05644925
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-11-14
2024-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PICSO+PCI
PiCSO Impulse System
The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1.
Percutaneous Coronary Intervention (PCI)
Minimally invasive procedures used to open clogged coronary arteries
Standard PCI
Percutaneous Coronary Intervention (PCI)
Minimally invasive procedures used to open clogged coronary arteries
Interventions
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PiCSO Impulse System
The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1.
Percutaneous Coronary Intervention (PCI)
Minimally invasive procedures used to open clogged coronary arteries
Eligibility Criteria
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Inclusion Criteria
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. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
4. Pre-PCI TIMI flow 0-1.
5. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
6. The patient is eligible for primary PCI.
7. Informed consent received and signed for study enrollment.
Exclusion Criteria
2. Implants or foreign bodies in the coronary sinus.
3. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
4. Known pregnancy or breastfeeding.
5. Known coagulopathy.
6. Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
7. Known large pericardial effusion or cardiac tamponade.
8. Central hemodynamically relevant left-right shunt.
9. Previous MI or Coronary Artery Bypass Graft (CABG).
10. Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
11. Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
12. Unconscious at presentation.
13. Need for circulatory support.
14. Need for invasive mechanical ventilation.
15. Need for temporal intravenous pacemaker.
16. Patient not suitable for femoral access.
17. Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
18. Known epicardial stenosis greater than 50% distal to the culprit LAD lesion.
19. Active participation in another drug or device investigational trial.
20. Medical, social or psychological condition that limits the ability of patient to participate in the study.
21. Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.
18 Years
ALL
No
Sponsors
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Miracor Medical SA
INDUSTRY
Fundacio Privada Mon Clinic Barcelona
OTHER
Responsible Party
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Other Identifiers
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PiCSO-STEMI
Identifier Type: -
Identifier Source: org_study_id
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