Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-04-17 @ 10:13 PM
Study NCT ID:
NCT01669850
Status:
TERMINATED
Last Update Posted:
2015-09-07
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-03-18', 'releaseDate': '2019-02-22'}], 'estimatedResultsFirstSubmitDate': '2019-02-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'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'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'minimal accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost', 'timeFrame': '1 year postoperative', 'description': 'Cost for the vascular clip device will be compared to cost of the handsewn technique.'}], 'primaryOutcomes': [{'measure': 'Patency rates', 'timeFrame': '2 years postoperative', 'description': 'Patency will be assessed and the fistula considered patent if it has been accessed for dialysis at least once, or based on clinical assessment with palpable thrill if dialysis access has not been attempted.'}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '2 years postoperative', 'description': 'Complications will be monitored intraoperatively, and postoperatively. These include any re-interventions, and wound complications, infection, hematoma, thrombosis , steal syndrome, distal ischemia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Arteriovenous fistula', 'Surgical anastomosis', 'Complications', 'Patency', 'Dialysis access'], 'conditions': ['Arteriovenous Fistula Complications and Failure']}, 'referencesModule': {'references': [{'pmid': '11296337', 'type': 'BACKGROUND', 'citation': 'Baguneid MS, Goldner S, Fulford PE, Hamilton G, Walker MG, Seifalian AM. A comparison of para-anastomotic compliance profiles after vascular anastomosis: nonpenetrating clips versus standard sutures. J Vasc Surg. 2001 Apr;33(4):812-20. doi: 10.1067/mva.2001.112806.'}, {'pmid': '14672769', 'type': 'BACKGROUND', 'citation': 'Lin PH, Bush RL, Nelson JC, Lam R, Paladugu R, Chen C, Quinn G, Lumsden AB. A prospective evaluation of interrupted nitinol surgical clips in arteriovenous fistula for hemodialysis. Am J Surg. 2003 Dec;186(6):625-30. doi: 10.1016/j.amjsurg.2003.08.007.'}, {'pmid': '22104322', 'type': 'BACKGROUND', 'citation': 'Varcoe RL, Teo AB, Pelletier MH, Yu Y, Yang JL, Crowe PJ, Walsh WR. An arteriovenous fistula model of intimal hyperplasia for evaluation of a nitinol U-Clip anastomosis. Eur J Vasc Endovasc Surg. 2012 Feb;43(2):224-31. doi: 10.1016/j.ejvs.2011.11.002. Epub 2011 Nov 21.'}, {'pmid': '12891102', 'type': 'BACKGROUND', 'citation': 'Shenoy S, Miller A, Petersen F, Kirsch WM, Konkin T, Kim P, Dickson C, Schild AF, Stewart L, Reyes M, Anton L, Woodward RS. A multicenter study of permanent hemodialysis access patency: beneficial effect of clipped vascular anastomotic technique. J Vasc Surg. 2003 Aug;38(2):229-35. doi: 10.1016/s0741-5214(03)00412-9.'}, {'pmid': '16193217', 'type': 'BACKGROUND', 'citation': 'Shenoy S, Woodward RS. Economic impact of the beneficial effect of changing vascular anastomotic technique in hemodialysis access. Vasc Endovascular Surg. 2005 Sep-Oct;39(5):437-43. doi: 10.1177/153857440503900509.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.', 'detailedDescription': 'End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Need for AVF creation for vascular access for planned hemodialysis (within 1 year).\n* The planned AVF site must be naïve of prior AVF creations.\n* Vein mapping studies completed\n* 2.5 - 3mm minimum vein diameter on mapping\n\nExclusion Criteria:\n\n* Less than 18 years of age.\n* Inability to provide consent.\n* Previous failed AVFs in both arms.\n* Contraindications to AVF creation:\n\n * ipsilateral proximal venous and arterial occlusion or stenosis\n * systemic or local infection\n * too ill to operate\n* Anticipated inability to keep 30-day postoperative follow-up appointment.'}, 'identificationModule': {'nctId': 'NCT01669850', 'briefTitle': 'Clipped Versus Handsewn Arteriovenous Fistula Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'Gundersen Lutheran Medical Foundation'}, 'officialTitle': 'The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas', 'orgStudyIdInfo': {'id': '2-12-07-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clipped anastomosis', 'description': 'A vascular clip device will be used to create the anastomosis during arteriovenous fistula creation.', 'interventionNames': ['Device: Clipped anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Handsewn anastomosis', 'description': 'A handsewn technique will be used to create the anastomosis in arteriovenous fistula creation.', 'interventionNames': ['Procedure: Handsewn anastomosis']}], 'interventions': [{'name': 'Clipped anastomosis', 'type': 'DEVICE', 'otherNames': ['Anastoclip (Le Maitre)'], 'description': 'The vascular clip devise will be used to complete the anastomosis during fistula creation.', 'armGroupLabels': ['Clipped anastomosis']}, {'name': 'Handsewn anastomosis', 'type': 'PROCEDURE', 'description': 'a handsewn anastomosis technique will be used during fistula creation.', 'armGroupLabels': ['Handsewn anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gundersen Lutheran Health System', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Clark A Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gundersen Lutheran Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gundersen Lutheran Medical Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gundersen Lutheran Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Advanced Research Associate, on behalf of Clark Davis, MD (PI)', 'investigatorFullName': 'Kara Kallies', 'investigatorAffiliation': 'Gundersen Lutheran Medical Foundation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-02-22', 'type': 'RELEASE'}, {'date': '2019-03-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kara Kallies, Advanced Research Associate, on behalf of Clark Davis, MD (PI), Gundersen Lutheran Medical Foundation'}}}}