Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT03189667
Status:
TERMINATED
Last Update Posted:
2019-05-01
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-27', 'mcpReleaseN': 5, 'releaseDate': '2021-04-01'}], 'estimatedResultsFirstSubmitDate': '2021-04-01'}}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-28', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AVF circuit patency', 'timeFrame': '12 month', 'description': 'Dialysis adequacy to be assessed based on functional criteria'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'intra procedural', 'description': '\\<30% residual stenosis without postdilation'}, {'measure': 'Access circuit dysfunction free survival', 'timeFrame': '12 month', 'description': 'Time to event based on functional criteria'}, {'measure': 'Target lesion restenosis free survival', 'timeFrame': '12 month', 'description': 'Time to event in case of new lesion causes circuit dysfunction'}, {'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': '12 month following the procedure', 'description': 'Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dysfunctional Dialysis Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': 'Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).', 'detailedDescription': 'Objectives of the Study:\n\nHypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons\n\nAim of the Study:\n\nCompare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.\n\nSpecific Objectives:\n\nPrimary functional endpoint: Access circuit patency based on functional criteria at 12 month.\n\nPrimary safety endpoint: Peri procedural complication rate\n\nSecondary endpoints:\n\n* Technical success (\\<30% residual stenosis without postdilation)\n* Access circuit dysfunction free survival (Time to event) based on functional criteria\n* Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria\n\n * \\>18 year old\n * Dysfunctional dialysis fistula\n* Radiocephalic\n* Brachiocephalic\n* Brachiobasilic\n\nClinical criteria for diagnosis of dysfunctional fistula:\n\n* Swelling of the fistula limb\n* Prolonged bleeding after withdrawing access needles\n* Abnormal pulsations or weak thrill.\n* Functional criteria for the diagnosis of dysfunctional criteria:\n* Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,\n* A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.\n* Non-thrombosed\n\nExclusion Criteria:\n\n* Dysfunctional arteriovenous (AV) grafts\n* Thrombosed fistulas\n* Intra-stent stenosis\n* Stenoses not responding to balloon angioplasty and requiring stenting.\n* Stenosis less than 50%\n* Surgical intervention that excludes the treatment segment from the access circuit\n* Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure\n* Location of isolated stenosis central to the thoracic inlet.\n* Women who are breastfeeding, pregnant or are intending to become pregnant\n* Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.\n* Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel'}, 'identificationModule': {'nctId': 'NCT03189667', 'briefTitle': 'Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula', 'orgStudyIdInfo': {'id': 'RC16/035/R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug coated balloon angioplasty', 'description': '* Vessel preparation with Pre dilatation\n* Vessel treatment with Drug-coated balloon', 'interventionNames': ['Device: Vessel preparation with angioplasty', 'Device: Drug coated balloon angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plain balloon angioplasty', 'description': '* Vessel preparation with Pre dilatation\n* Vessel treatment with additional Plain balloon angioplasty:', 'interventionNames': ['Device: Vessel preparation with angioplasty', 'Device: Plain balloon angioplasty']}], 'interventions': [{'name': 'Vessel preparation with angioplasty', 'type': 'DEVICE', 'description': 'Vessel preparation with Pre dilatation:\n\n* All lesions to be predilated with high pressure balloons until waist is obliterated.\n* At least two minutes dilatation.\n* Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%.\n* Multiple lesions:\n\n * To be treated with single balloon if possible.\n * To be treated with multiple inflation if cannot be covered with single balloon.', 'armGroupLabels': ['Drug coated balloon angioplasty', 'Plain balloon angioplasty']}, {'name': 'Plain balloon angioplasty', 'type': 'DEVICE', 'description': 'Plain balloon angioplasty\n\n* Vessel treatment with additional Plain balloon angioplasty:\n* Inflation to nominal pressure for at least 1 minute.\n* Balloon size: similar to predilation balloon.', 'armGroupLabels': ['Plain balloon angioplasty']}, {'name': 'Drug coated balloon angioplasty', 'type': 'DEVICE', 'description': 'Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation.\n\n* Inflation to nominal pressure for at least 1 minute.\n* Balloon size: similar to the predilation balloon.\n* New drug coated balloon will be required for each lesion.', 'armGroupLabels': ['Drug coated balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King ABdulaziz Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Mohammad Arabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz Medical City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}