Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02902094
Status:
UNKNOWN
Last Update Posted:
2016-09-15
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency', 'timeFrame': '12 months', 'description': 'Primary end point is a composite of one or more of :\n\n* \\>50% stenosis of index lesion requiring re-intervention\n* Re-intervention of index lesion due to clinical indications without 50% re-stenosis\n* Fistula failure'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Time of baseline index intervention', 'description': 'Defined as \\<30% residual stenosis using only the study balloon to which the patient was randomised'}, {'measure': 'Assisted technical success of balloon angioplasty', 'timeFrame': 'At time of baseline index intervention', 'description': 'Defined as \\<30% residual stenosis using adjunctive procedures in addition to study balloon'}, {'measure': 'Successful use of fistula for dialysis', 'timeFrame': 'In the 12 months following baseline index intervention', 'description': 'Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion'}, {'measure': 'Secondary patency of the access circuit', 'timeFrame': 'In the 12 months following baseline index intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Native Arteriovenous Fistula', 'Stenosis']}, 'descriptionModule': {'briefSummary': 'DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.\n* Fistula has been in use for at least 1 month and is \\> 6 weeks old\n* Brachiocephalic AV fistula\n* Brachiobasilic AV fistula\n* Radiocephalic AV fistula (both proximal and distal)\n* Participant \\>/=18 yrs old\n* Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)\n* Participant is able to give valid informed consent\n\nExclusion Criteria:\n\n* Allergy to iodinated Intravenous contrast\n* Allergy to Paclitaxel\n* Prosthetic grafts\n* Long or tandem lesions that cannot be treated with a single DEB\n* Thrombosed Arterio-Venous fistulas\n* Women who are breastfeeding, pregnant or intending to become pregnant\n* Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT02902094', 'acronym': 'DeVA', 'briefTitle': 'Drug Eluting Balloon Venoplasty in AV Fistula Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Birmingham'}, 'officialTitle': 'Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)', 'orgStudyIdInfo': {'id': 'RRK5479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Drug eluting angioplasty balloons', 'interventionNames': ['Device: Drug eluting balloons']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Non-drug eluting balloons', 'interventionNames': ['Device: Non drug eluting balloons']}], 'interventions': [{'name': 'Drug eluting balloons', 'type': 'DEVICE', 'armGroupLabels': ['Experimental']}, {'name': 'Non drug eluting balloons', 'type': 'DEVICE', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'West Midlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'R G Jones, Dr', 'role': 'CONTACT'}], 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'N E Anderson', 'role': 'CONTACT', 'phone': '+441216272000'}], 'overallOfficials': [{'name': 'Robert Jones, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Birmingham NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}