Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT01398033
Status:
WITHDRAWN
Last Update Posted:
2015-08-05
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study stopped due to lack of patient inclusion', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary patency of target lesion assessed by quantitative angiography', 'timeFrame': '3 months after index procedure'}], 'secondaryOutcomes': [{'measure': 'Secondary patency of the target lesion assessed by quantitative angiography', 'timeFrame': '12 months after index procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infrapopliteal arteries', 'In-stent stenosis', 'long lesions', 'drug-coated balloon'], 'conditions': ['In-stent Stenosis of Infrapopliteal Arteries']}, 'descriptionModule': {'briefSummary': 'There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.\n\nThe aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.', 'detailedDescription': 'In this prospective, double-blind, randomised, multi-centre study the use of the already certified coated balloon and an uncoated balloon is evaluated in patients with in-stent restenoses/reocclusions of the lower limb artery. The whole lesion length should be covered by the balloon so that proximal and distal overlap of the lesion by a minimum of 5mm is assured. Based on the current literature the average restenoses rate of the lower limb arteries after percutaneous transluminal angioplasty of an in-stent restenosis is 70% after 6 months. Assuming the restenosis rate reduces to 30% after percutaneous transluminal angioplasty using a drug-coated balloon, with a significance level of Alpha=0.05 (bilateral) and a power Beta=0.8, the enrolment of 100 patients is required in order to show a significant difference between treatment groups, considering a dropout rate of 30%. The choice of treatment will be distributed in a randomised, double blind procedure.\n\nThe study duration per patient is 2 years. Clinical follow-up evaluations will take place after 3 and 6 months and after 1 and 2 years. After 3 month and 12 months an angiography of the target vessel will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 50 years\n* Signed declaration of consent\n* Subject is willing and able to participate in all the planned evaluations of the study protocol\n* Arterial occlusion disease stage 3 - 6 Rutherford-Becker\n* Subject with an in-stent stenosis over 70% of the vascular lumen diameter of the tibioperoneal trunc and/or the posterior tibial artery and/or of the anterior tibial artery and/or peroneal artery. Here vascular segments, which are affected continuous (including stent), proximal or distal of the stent by a relevant (re)stenosis, are treated according to randomisation\n* The length of the target lesion(s) should not exceed 290mm\n* In total four drug-coated balloons are enough to treat a maximum of two lesions\n* The target lesion's lumen diameter is between 2.0mm and 3.5mm\n* Successful passage of the wire to the target lesion before randomisation\n\nExclusion Criteria:\n\n* Coagulopathy\n* Pregnancy\n* Contraindications for antiplatelet or heparin\n* Factors which exclude a follow up\n* Life expectancy \\<12 months\n* Known allergies to contrast agents and/or Clopidogrel and/or Aspirin\n* \\>50% stenosis distal of the target lesion\n* Visible thrombus in the target lesion\n* Lytic therapy 72 hours before the planned intervention\n* Aneurysm of the femoral or popliteal artery\n* Intervention of focal lesions of the femoral or popliteal artery may be carried out before treatment of the target lesion in order to enhance the inflow in the lower limb"}, 'identificationModule': {'nctId': 'NCT01398033', 'acronym': 'BAIR', 'briefTitle': 'Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis', 'organization': {'class': 'OTHER', 'fullName': 'Herz-Zentrums Bad Krozingen'}, 'officialTitle': 'Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis', 'orgStudyIdInfo': {'id': 'FW-014-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug-coated balloon', 'description': '1. pre-dilatation of the target lesion with a non-coated balloon.\n2. treatment of the target lesion with the paclitaxel-coated balloon', 'interventionNames': ['Device: paclitaxel-coated balloon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-coated balloon', 'description': 'Treatment of the target lesion with plain balloon angioplasty.', 'interventionNames': ['Device: non-coated balloon']}], 'interventions': [{'name': 'paclitaxel-coated balloon', 'type': 'DEVICE', 'description': 'Balloon is coated with paclitaxel in a concentration of 3µg/mm2.', 'armGroupLabels': ['Drug-coated balloon']}, {'name': 'non-coated balloon', 'type': 'DEVICE', 'description': 'percutaneous transluminal angioplasty with a non-coated balloon', 'armGroupLabels': ['non-coated balloon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79219', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herzzentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}], 'overallOfficials': [{'name': 'Aljoscha Rastan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzzentrum Bad Krozingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herz-Zentrums Bad Krozingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Heart Center Freiburg - Bad Krozingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Aljoscha Rastan', 'investigatorAffiliation': 'Herz-Zentrums Bad Krozingen'}}}}