Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01255956
Status:
UNKNOWN
Last Update Posted:
2011-01-25
First Post:
2010-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2010-12-06', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of repeated restenosis angiographically evidenced', 'timeFrame': 'at 9 months'}, {'measure': 'Neointimal volume assessed by intravascular ultrasound (IVUS)', 'timeFrame': 'at 9 months'}, {'measure': 'Late lumen loss and neointimal volume assessed by optical coherence tomography (OCT)', 'timeFrame': 'at 9 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of repeated target lesion revascularization (TLR)', 'timeFrame': 'at 9 months'}, {'measure': 'Incidence of repeated target vessel revascularization (TVR)', 'timeFrame': 'at 9 months'}, {'measure': 'Incidence of death', 'timeFrame': 'at 9 months'}, {'measure': 'Incidence of myocardial infarction', 'timeFrame': 'at 9 months'}, {'measure': 'Incidence of brain stroke', 'timeFrame': 'at 9 months'}, {'measure': 'Incidence of in-stent thrombosis', 'timeFrame': 'at 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['restenosis', 'ISR', 'in-stent restenosis', 'drug eluting stent', 'rapamycin eluting stent', 'paclitaxel eluting balloon catheter'], 'conditions': ['In-Stent Restenosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.', 'detailedDescription': "Study aims:\n\n* Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization\n* Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects\n* Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects\n* Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up\n* Analysis of direct and indirect medical costs of alternative treatment strategies\n\nStudy group:\n\n200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups:\n\n* Patients treated with rapamycin eluting stent (n=100)\n* Patients treated with paclitaxel eluting balloon catheter (n=100)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* at least 18 years of age\n* symptomatic restenosis in bare metal stent implanted in native coronary artery\n* angina pectoris\n* ischemia evidenced by non-invasive diagnostic tests\n* angiographically evidenced in-stent restenosis \\> 50% assessed by quantitative coronary angiography (QCA)\n* vessel diameter \\> 2,5 mm\n\nClinical exclusion criteria:\n\n* myocardial infarction within less than past 72 hours\n* heart failure with left ventricular ejection fraction (LVEF) \\< 30%\n* chronic renal failure with significant impairment of glomerular filtration (creatinine \\> 2 mg/dl)\n* hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel\n* hypersensitivity to contrast\n* other diseases that may cause significant deterioration in long-term prognosis\n* acute or chronic inflammatory diseases\n* patients who are unwilling to consent for participation in the study\n\nAngiographic exclusion criteria:\n\n* significant stenosis in left main coronary artery (LM)\n* multivessel disease qualifying for coronary artery bypass grafting (CABG)\n* anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance\n* vessel diameter \\< 2,5 mm\n* restenotic lesion length \\> 30 mm"}, 'identificationModule': {'nctId': 'NCT01255956', 'acronym': 'ISRII', 'briefTitle': 'Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Efficacy Evaluation of In-bare Metal Stent Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter. Study With Intravascular Ultrasound and Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'Restenoza II 4.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycin eluting stent', 'description': 'Patients treated with rapamycin eluting stent (n=100)', 'interventionNames': ['Device: Rapamycin eluting stent implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Paclitaxel eluting balloon catheter', 'description': 'Patients treated with paclitaxel eluting balloon catheter (n=100)', 'interventionNames': ['Device: Paclitaxel eluting balloon catheter']}], 'interventions': [{'name': 'Rapamycin eluting stent implantation', 'type': 'DEVICE', 'description': 'Rapamycin eluting stent implantation for in-stent restenosis treatment', 'armGroupLabels': ['Rapamycin eluting stent']}, {'name': 'Paclitaxel eluting balloon catheter', 'type': 'DEVICE', 'description': 'Paclitaxel eluting balloon catheter for in-stent restenosis treatment', 'armGroupLabels': ['Paclitaxel eluting balloon catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-628', 'city': 'Warsaw', 'state': 'Alpejska 42', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Adam Witkowski, MD, PhD', 'role': 'CONTACT', 'phone': '+48 22 812 41 64'}, {'name': 'Adam Witkowski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instytut Kardiologii w Warszawie-Aninie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-097', 'city': 'Warsaw', 'state': 'Banacha 1a', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Janusz Kochman, MD, PhD', 'role': 'CONTACT', 'phone': '+48 22 599 19 58'}, {'name': 'Janusz Kochman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Katedra i Klinika Kardiologii Warszawskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '91-347', 'city': 'Lodz', 'state': 'Kniaziewicza 1/5', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Zbigniew Peruga, MD, PhD', 'role': 'CONTACT', 'phone': '+48 42 251 62 21'}, {'name': 'Zbigniew Peruga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinika Kardiologii z Kliniką Kardiochirurgii Uniwersyteckiego Szpitala Klinicznego w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '31-500', 'city': 'Krakow', 'state': 'Kopernika 17', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jacek Legutko, MD, PhD', 'role': 'CONTACT', 'phone': '+48 12 424 71 81'}, {'name': 'Jacek Legutko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Jacek Legutko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'II Department of Cardiology Medical College Jagiellonian University University Hospital in Krakow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCRI', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Medical University of Warsaw', 'oldOrganization': 'Medical University of Warsaw'}}}}