Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

Jagiellonian University

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction

Treatments: Device: Percutaneous thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00377650

JagiellonianU

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)