Myocardial Infarction
Conditions
Brief summary
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
Interventions
DEVICEPercutaneous thrombectomy
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead * Minimum 3 mm ST segment elevation in one leads * Vessel reference diameter \> 2.5 mm * When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation
Exclusion criteria
* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors * Active bleeding or coagutopathy * Prior CABG or PCI * Known ejection fraction EF \<35% * Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/ * LBBB, pacemaker rhythm * Severe calcifications * Previous Myocardial infarction * Stroke history * Patient directly after reanimation * Known thrombocytopenia- platelets \< 100 000 * Pregnancy * Cancer disease * No future patient cooperation expected * Patient's taking part in the other clinical trials * Fibrynolisis directly administered before PCI * Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis * Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors * Active bleeding or coagutopathy * Prior CABG or PCI * Known ejection fraction EF \<35% * Cardiogenic shock /SBP \< 90 mmHg, IABP and/or catheloamins usage/ * LBBB, pacemaker rhythm * Severe calcifications * Previous Myocardial infarction * Stroke history * Patient directly after reanimation * Known thrombocytopenia- platelets \< 100 000 * Pregnancy * Cancer disease * No future patient cooperation expected * Patient's taking part in the other clinical trials * Fibrynolisis directly administered before PCI * Renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis * Liver insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ST resolution >70% 60 minutes after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 | — |
| 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 | — |
| ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) | — |
Countries
Hungary, Italy, Poland
Contacts
Primary ContactDariusz Dudek, MD
Outcome results
None listed