Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 1:57 PM
Study NCT ID:
NCT00179192
Status:
WITHDRAWN
Last Update Posted:
2015-05-25
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney 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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], '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': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'non-enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['End Stage Renal Disease', 'ESRD', 'Chronic Maintenance Hemodialysis'], 'conditions': ['End-Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.\n\nIt is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week\n2. Have an arteriovenous (polytetrafluoroethylene) graft as vascular access\n3. Have a venous stenosis between 30% and 70% as determined by angiogram\n\nExclusion Criteria:\n\n1. Native arteriovenous fistula\n2. Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries \\>4\n3. Unwilling to participate\n4. Allergy to iodine\n5. Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)\n6. Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization\n7. Known hypercoagulable state'}, 'identificationModule': {'nctId': 'NCT00179192', 'briefTitle': 'Prevention and Treatment of Hemodialysis Vascular Access Malfunction', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Prevention and Treatment of Hemodialysis Vascular Access Malfunction', 'orgStudyIdInfo': {'id': '9318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'angioplasty intervention', 'interventionNames': ['Procedure: angioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'surgery intervention', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'angioplasty', 'type': 'PROCEDURE', 'description': 'angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist', 'armGroupLabels': ['2']}, {'name': 'surgery', 'type': 'PROCEDURE', 'description': "surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure", 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Talat A Ikizler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alp Ikizler', 'investigatorAffiliation': 'Vanderbilt University'}}}}