Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377650
Status:
UNKNOWN
Last Update Posted:
2007-01-17
First Post:
2006-09-14
Brief Title:
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial PIHRATE Trial
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 efficacypassing 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 GpIIbIIIa inhibitors or adenosine or nitroprosside final thrombus score 1
Study design
Multicenter prospective opened randomized
Primary endpoints
ST resolution 70 60 minutes after PCI
Secondary endpoints
Thrombectomy system efficacypassing 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 GpIIbIIIa inhibitors or adenosine or nitroprosside final thrombus score 1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None