Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-31 @ 2:08 AM
Study NCT ID:
NCT05173857
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from restenosis in treated vascular access', 'timeFrame': '12 months', 'description': 'Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up'}, {'measure': 'Stenosis or occlusion in treated vascular access', 'timeFrame': '12 months', 'description': 'Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis \\>50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)'}, {'measure': 'Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months', 'timeFrame': '12 months', 'description': 'Functional status of vascular access.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haemodialysis', 'Fistula', 'Stenosis', 'Paclitaxel', 'Drug-eluting balloon', 'Angioplasty'], 'conditions': ['Vascular Diseases', 'Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes.\n\nMethods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active dialysis with a mature upper extremity dysfunctional haemodialysis access\n* Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location\n* Adult (\\>18 years)\n* Target vessel diameter 3-8mm\n\nExclusion Criteria:\n\n* Thrombosed access\n* In stent restenosis\n* Pregnancy\n* Age less than 18 years'}, 'identificationModule': {'nctId': 'NCT05173857', 'briefTitle': 'Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'TF1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug Eluting Balloon (DEB)', 'description': 'Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology.\n\nDrug: Paclitaxel (PTX). Name of Device: Advance PTX', 'interventionNames': ['Device: Advance PTX', 'Drug: Paclitaxel (PTX)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Plain Old Balloon Angioplasty (POBA)', 'description': 'Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty.\n\nDrug: None. Name of Device: Advance LP (Low Profile)', 'interventionNames': ['Device: Advance LP (Low Profile)']}], 'interventions': [{'name': 'Advance PTX', 'type': 'DEVICE', 'description': 'PTA in Dysfunctional Haemodialysis Access', 'armGroupLabels': ['Drug Eluting Balloon (DEB)']}, {'name': 'Advance LP (Low Profile)', 'type': 'DEVICE', 'description': 'Plain Old Balloon Angioplasty (POBA)', 'armGroupLabels': ['Plain Old Balloon Angioplasty (POBA)']}, {'name': 'Paclitaxel (PTX)', 'type': 'DRUG', 'description': 'Paclitaxel (PTX)', 'armGroupLabels': ['Drug Eluting Balloon (DEB)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Vascular Surgeon', 'investigatorFullName': 'Torbjorn Fransson', 'investigatorAffiliation': 'Skane University Hospital'}}}}