Myocardial Infarction Clinical Trial
Official title:
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.
Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy
system leading to thrombus reduction.
Study design:
Multicenter, prospective, opened, randomized.
Primary endpoints:
ST resolution >70% 60 minutes after PCI
Secondary endpoints:
Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI
thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR – infarct size, measurement of left
ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO:
measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection
fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI,
rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite
angiographic adverse events including: distal embolisation, transient no-reflow or slow
flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside,
final thrombus score >1
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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