Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 5:22 AM
Study NCT ID:
NCT01083394
Status:
UNKNOWN
Last Update Posted:
2014-03-10
First Post:
2010-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-07', 'studyFirstSubmitDate': '2010-02-26', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage diameter stenosis', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '6 and 24 months'}, {'measure': 'Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)', 'timeFrame': '6 Months'}, {'measure': 'Time to onset of any of MAPE', 'timeFrame': '3-24 months'}, {'measure': 'Binary restenosis rate', 'timeFrame': '6 months'}, {'measure': 'Percentage diameter stenosis in duplex ultrasound', 'timeFrame': '6 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PTA', 'paclitaxel', 'restenosis'], 'conditions': ['Peripheral Vascular Disease']}, 'referencesModule': {'references': [{'pmid': '28743787', 'type': 'DERIVED', 'citation': 'Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial. J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.', 'detailedDescription': 'The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)\n* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study\n\nExclusion Criteria:\n\n* Acute ischemia and/or acute thrombosis of the SFA\n* Untreated ipsilateral iliac artery stenosis \\>70%\n* Not at least one vessel run-off\n* Popliteal involvement with stenosis \\>70%\n* Severe renal insufficiency (GFR \\<30 ml/min/m2)\n* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.\n* Pregnancy (present, suspected or planned) or positive pregnancy test.\n* Previous enrollment in this trial.\n* Patient's inability to fully cooperate with the study protocol."}, 'identificationModule': {'nctId': 'NCT01083394', 'acronym': 'ISAR-PEBIS', 'briefTitle': 'Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)', 'orgStudyIdInfo': {'id': 'GE IDE No. B00210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional PTA', 'description': 'In stent restenosis is treated with PTA using a conventional balloon.', 'interventionNames': ['Device: PTA', 'Procedure: Percutaneous Transluminal Angioplasty (PTA)']}, {'type': 'EXPERIMENTAL', 'label': 'PTA with PEB', 'description': 'In stent restenosis is treated with PTA using a paclitaxel eluting balloon.', 'interventionNames': ['Device: PTA with PEB', 'Procedure: Percutaneous Transluminal Angioplasty (PTA)']}], 'interventions': [{'name': 'PTA', 'type': 'DEVICE', 'otherNames': ['PACIFIC XTREME, Invatec'], 'description': 'PTA using a conventional balloon', 'armGroupLabels': ['conventional PTA']}, {'name': 'PTA with PEB', 'type': 'DEVICE', 'otherNames': ['IN.PACT PACIFIC, Invatec'], 'description': 'PTA using a paclitaxel eluting balloon', 'armGroupLabels': ['PTA with PEB']}, {'name': 'Percutaneous Transluminal Angioplasty (PTA)', 'type': 'PROCEDURE', 'otherNames': ['PACIFIC XTREME or IN.PACT PACIFIC balloons'], 'description': 'Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon', 'armGroupLabels': ['PTA with PEB', 'conventional PTA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ilka V. Ott, MD', 'role': 'CONTACT', 'email': 'ott@dhm.mhn.de', 'phone': '+49 89 4140', 'phoneExt': '4360'}, {'name': 'Ilka V. Ott, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '1. Medizinische Klinik, Klinikum rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Massimiliano Fusaro, MD', 'role': 'CONTACT', 'email': 'fusaro@dhm.mhn.de', 'phone': '+49 89 1218', 'phoneExt': '4566'}, {'name': 'Tarek Ibrahim, MD', 'role': 'CONTACT', 'email': 'ibrahim@dhm.mhn.de', 'phone': '+49 89 1218', 'phoneExt': '4016'}, {'name': 'Massimiliano Fusaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deutsches Herzzentrum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Julinda Mehilli, MD', 'role': 'CONTACT', 'email': 'mehilli@dhm.mhn.de', 'phone': '+49 89 12 18', 'phoneExt': '4582'}, {'name': 'Ilka V. Ott, MD', 'role': 'CONTACT', 'email': 'ott@dhm.de', 'phone': '+49 89 41 40', 'phoneExt': '4360'}], 'overallOfficials': [{'name': 'Adnan Kastrati, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Deutsches Herzzentrum Muenchen'}, {'name': 'Ilka V. Ott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}