Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 1:11 PM
Study NCT ID:
NCT00377650
Status:
UNKNOWN
Last Update Posted:
2007-01-17
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polish-Italian-Hungarian RAndomized ThrombEctomy Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017131', 'term': 'Thrombectomy'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2007-01-16', 'studyFirstSubmitDate': '2006-09-14', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ST resolution >70% 60 minutes after PCI'}], 'secondaryOutcomes': [{'measure': 'Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1'}, {'measure': 'TIMI 3 flow after PCI'}, {'measure': 'MBG 3'}, {'measure': 'CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)'}, {'measure': 'ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)'}, {'measure': 'Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up'}, {'measure': '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'}]}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '21095287', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.\n\nStudy design:\n\nMulticenter, prospective, opened, randomized.\n\nPrimary endpoints:\n\nST resolution \\>70% 60 minutes after PCI\n\nSecondary endpoints:\n\nThrombectomy 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead\n* Minimum 3 mm ST segment elevation in one leads\n* Vessel reference diameter \\> 2.5 mm\n* When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation\n\nExclusion Criteria:\n\n* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors\n* Active bleeding or coagutopathy\n* Prior CABG or PCI\n* Known ejection fraction EF \\<35%\n* Cardiogenic shock /SBP \\< 90 mmHg, IABP and/or catheloamins usage/\n* LBBB, pacemaker rhythm\n* Severe calcifications\n* Previous Myocardial infarction\n* Stroke history\n* Patient directly after reanimation\n* Known thrombocytopenia- platelets \\< 100 000\n* Pregnancy\n* Cancer disease\n* No future patient cooperation expected\n* Patient's taking part in the other clinical trials\n* Fibrynolisis directly administered before PCI\n* Renal insufficiency (creatynine \\> 220 µmol/ml), hemodialysis\n* Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors\n* Active bleeding or coagutopathy\n* Prior CABG or PCI\n* Known ejection fraction EF \\<35%\n* Cardiogenic shock /SBP \\< 90 mmHg, IABP and/or catheloamins usage/\n* LBBB, pacemaker rhythm\n* Severe calcifications\n* Previous Myocardial infarction\n* Stroke history\n* Patient directly after reanimation\n* Known thrombocytopenia- platelets \\< 100 000\n* Pregnancy\n* Cancer disease\n* No future patient cooperation expected\n* Patient's taking part in the other clinical trials\n* Fibrynolisis directly administered before PCI\n* Renal insufficiency (creatynine \\> 220 µmol/ml), hemodialysis\n* Liver insufficiency"}, 'identificationModule': {'nctId': 'NCT00377650', 'briefTitle': 'Polish-Italian-Hungarian RAndomized ThrombEctomy Trial', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.', 'orgStudyIdInfo': {'id': 'JagiellonianU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous thrombectomy', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pécs', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Ivan Horvath, MD', 'role': 'CONTACT', 'email': 'ivan.g.horvath@aok.pte.hu'}, {'name': 'Ivan Horvath, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute, Medical School of University Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Rubartelli, MD', 'role': 'CONTACT', 'email': 'paolo.rubartelli@villascassi.it'}, {'name': 'Paolo Rubartelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiology Department Hospital Villascassi', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Burzotta, MD', 'role': 'CONTACT', 'email': 'f.burzotta@rm.unicatt.it'}, {'name': 'Francesco Burzotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Cardiology, Catholic University', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Andrzej Ochala, Md', 'role': 'CONTACT', 'email': 'aochala@poczta.onet.pl'}, {'name': 'Andrzej Ochała, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Górnośląskie Centrum Medyczne', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-501', 'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Waldemar A Mielecki, MD', 'role': 'CONTACT', 'email': 'wmielecki@su.krakow.pl', 'phone': '124247181', 'phoneExt': '+48'}, {'name': 'Dariusz Dudek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Waldemar A Mielecki, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zaklad Hemodynamiki i Angiokardiohrafii IK CMUJ', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Nowy Sącz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Renata Korpak-Wysocka, MD', 'role': 'CONTACT', 'phone': '184407487', 'phoneExt': '+48'}, {'name': 'Renata Korpak-Wysocka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dawid Giszterowicz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ', 'geoPoint': {'lat': 49.62177, 'lon': 20.69705}}, {'city': 'Przemyśl', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Andrzej Wiśniewski, MD', 'role': 'CONTACT', 'phone': '166775000', 'phoneExt': '+48'}, {'name': 'Andrzej Wiśniewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Szpital Wojewódzki w Przemyślu', 'geoPoint': {'lat': 49.78498, 'lon': 22.76728}}, {'zip': '04-628', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Adam Witkowski, MD', 'role': 'CONTACT', 'email': 'witkowski@hbz.pl'}, {'name': 'Adam Witkowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instytut Kardiologii im.Prymasa Tysiaclecia Sefana Kardynala Wyszynskiego', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Zabrze', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Mariusz Gasior, MD', 'role': 'CONTACT', 'email': 'm.gasior@sccs.pl'}, {'name': 'Mariusz Gasior, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Slaskie Centrum Chorob Serca', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'centralContacts': [{'name': 'Dariusz Dudek, MD', 'role': 'CONTACT', 'email': 'mcdudek@cyf-kr.edu.pl', 'phone': '124247181', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Dariusz Dudek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}}}}