A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients (NCT05497011) | Clinical Trial Compass
WithdrawnNot Applicable
A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
Stopped: Study terminated due to lack of financing
0Started 2023-03-30
Plain-language summary
The objective of this study is to assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to percutaneous coronary intervention (PCI) compared to PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old
✓. Culprit lesion in proximal or mid left anterior descending artery (LAD)
✓. Pre-PCI TIMI flow 0, 1 or 2
✓. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h
✓. Electrocardiogram (ECG) evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
✓. Emergent PCI will be performed according to national and local hospital guidelines
✓. Consent per approved national IRB/EC specific requirements prior to the procedure.
Exclusion criteria
✕. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
✕. Implants or foreign bodies in the coronary sinus
✕. Left main disease \>= 50%
✕. Need for treatment of any vessel other than the LAD (or its branches) during the index procedure or before the 5 ± 2 days study CMR.
✕. Known allergy to polyurethanes, polyethylene terephthalate (PET) or stainless steel, both heparin and bivalirudin, or all of clopidogrel, ticagrelor or prasugrel that cannot be adequately pre-medicated
What they're measuring
1
12% performance goal rate of PiCSO device or PiCSO procedure related adverse events reported through 30 days