Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as … (NCT04566289) | Clinical Trial Compass
WithdrawnNot Applicable
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Stopped: Study terminated due to lack of financing
Germany0Started 2022-10-01
Plain-language summary
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years old
✓. Culprit lesion in proximal or mid LAD
✓. ST-segment elevation
✓. Pre-PCI TIMI flow 0 or 1.
✓. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
✓. Patient is deemed eligible for PCI
✓. Consent as per approved national ethical committee specific requirements prior to the procedure.
Exclusion criteria
✕. Patients with contraindications to percutaneous insertion or angiography
✕. Patients with implants or foreign bodies in the coronary sinus
✕. Known allergy to polyurethanes, PET or stainless steel
✕. Known pregnancy or breast feeding
✕. Known pericardial effusion or cardiac tamponade
✕. Known central hemodynamically relevant left/right shunt
✕. Patients with symptom onset \> 12 hours
✕
What they're measuring
1
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI