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Sponsored by: |
Jagiellonian University |
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Information provided by: | Jagiellonian University |
ClinicalTrials.gov Identifier: | NCT00377650 |
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
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Device: Percutaneous thrombectomy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial. |
Estimated Enrollment: | 200 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dariusz Dudek, MD | 124247181 ext +48 | mcdudek@cyf-kr.edu.pl |
Hungary | |
Institute, Medical School of University Pecs | Recruiting |
Pecs, Hungary | |
Contact: Ivan Horvath, MD ivan.g.horvath@aok.pte.hu | |
Principal Investigator: Ivan Horvath, MD | |
Italy | |
Institute of Cardiology, Catholic University | Recruiting |
Rome, Italy | |
Contact: Francesco Burzotta, MD f.burzotta@rm.unicatt.it | |
Principal Investigator: Francesco Burzotta, MD | |
Cardiology Department Hospital Villascassi | Recruiting |
Genova, Italy | |
Contact: Paolo Rubartelli, MD paolo.rubartelli@villascassi.it | |
Principal Investigator: Paolo Rubartelli, MD | |
Poland | |
Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ | Recruiting |
Krakow, Poland, 31-501 | |
Contact: Waldemar A Mielecki, MD 124247181 ext +48 wmielecki@su.krakow.pl | |
Principal Investigator: Dariusz Dudek, MD | |
Sub-Investigator: Waldemar A Mielecki, MD | |
Szpital Wojewódzki w Przemyślu | Recruiting |
Przemyśl, Poland | |
Contact: Andrzej Wiśniewski, MD 166775000 ext +48 | |
Principal Investigator: Andrzej Wiśniewski, MD | |
Górnośląskie Centrum Medyczne | Recruiting |
Katowice, Poland | |
Contact: Andrzej Ochala, Md aochala@poczta.onet.pl | |
Principal Investigator: Andrzej Ochała, MD | |
Slaskie Centrum Chorob Serca | Recruiting |
Zabrze, Poland | |
Contact: Mariusz Gasior, MD m.gasior@sccs.pl | |
Principal Investigator: Mariusz Gasior, MD | |
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ | Recruiting |
Nowy Sacz, Poland | |
Contact: Renata Korpak-Wysocka, MD 184407487 ext +48 | |
Principal Investigator: Renata Korpak-Wysocka, MD | |
Sub-Investigator: Dawid Giszterowicz, MD | |
Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego | Recruiting |
Warszawa, Poland, 04-628 | |
Contact: Adam Witkowski, MD witkowski@hbz.pl | |
Principal Investigator: Adam Witkowski, MD |
Principal Investigator: | Dariusz Dudek, MD | Jagiellonian University Medical College |
Study ID Numbers: | JagiellonianU |
Study First Received: | September 14, 2006 |
Last Updated: | January 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00377650 |
Health Authority: | Poland: Ministry of Health |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |