NCT00377650

Polish-Italian-Hungarian RAndomized ThrombEctomy Trial

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Percutaneous thrombectomy

Timeline

• Start date: 2005-09-01
• Completion: 2007-12-01
• First posted: 2006-09-18
• Last updated: 2007-01-17

Locations

9 sites across 3 countries: Hungary, Italy, Poland