Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

Study Overview
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Brief Summary
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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

Official Title
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Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: Percutaneous thrombectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous thrombectomy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ST resolution >70% 60 minutes after PCI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |