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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Institute, Medical School of University Pecs
Pécs, Hungary
RECRUITINGCardiology Department Hospital Villascassi
Genova, Italy
RECRUITINGInstitute of Cardiology, Catholic University
Rome, Italy
RECRUITINGGórnośląskie Centrum Medyczne
Katowice, Poland
RECRUITINGZaklad Hemodynamiki i Angiokardiohrafii IK CMUJ
Krakow, Poland
RECRUITINGOddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ
Nowy Sącz, Poland
RECRUITINGSzpital Wojewódzki w Przemyślu
Przemyśl, Poland
RECRUITINGInstytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego
Warsaw, Poland
RECRUITINGSlaskie Centrum Chorob Serca
Zabrze, Poland
RECRUITINGST resolution >70% 60 minutes after PCI
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
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