Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
1 other identifier
interventional
200
3 countries
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2005
Typical duration for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 17, 2007
January 1, 2007
September 14, 2006
January 16, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
ST resolution >70% 60 minutes after PCI
Secondary Outcomes (7)
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)
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Institute, Medical School of University Pecs
Pécs, Hungary
Cardiology Department Hospital Villascassi
Genova, Italy
Institute of Cardiology, Catholic University
Rome, Italy
Górnośląskie Centrum Medyczne
Katowice, Poland
Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ
Krakow, 31-501, Poland
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ
Nowy Sącz, Poland
Szpital Wojewódzki w Przemyślu
Przemyśl, Poland
Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego
Warsaw, 04-628, Poland
Slaskie Centrum Chorob Serca
Zabrze, Poland
Related Publications (1)
Dudek D, Mielecki W, Burzotta F, Gasior M, Witkowski A, Horvath IG, Legutko J, Ochala A, Rubartelli P, Wojdyla RM, Siudak Z, Buchta P, Pregowski J, Aradi D, Machnik A, Hawranek M, Rakowski T, Dziewierz A, Zmudka K. Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial). Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024.
PMID: 21095287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dariusz Dudek, MD
Jagiellonian University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 18, 2006
Study Start
September 1, 2005
Study Completion
December 1, 2007
Last Updated
January 17, 2007
Record last verified: 2007-01