Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-06 @ 12:52 AM
Study NCT ID:
NCT01970605
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silver Graft All Comers Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001807', 'term': 'Blood Vessel Prosthesis'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Freedom from perigraft fluid presence', 'timeFrame': '12 months', 'description': 'assessed through imaging (ultrasound, MRI, CT)'}], 'primaryOutcomes': [{'measure': 'graft patency', 'timeFrame': '12 months', 'description': '12-month patency assessed with duplex ultrasound'}], 'secondaryOutcomes': [{'measure': 'Freedom from infection', 'timeFrame': 'at 12 months', 'description': 'assessed through clinical parameters, imaging (ultrasound, MRI, CT), bacterial cultures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aneurysm', 'Graft Failure', 'Graft Infection']}, 'referencesModule': {'references': [{'pmid': '23508393', 'type': 'BACKGROUND', 'citation': 'Zegelman M, Guenther G, Waliszewski M, Pukacki F, Stanisic MG, Piquet P, Passon M, Halloul Z, Tautenhahn J, Claey L, Agostinho C, Simici D, Doebrich D, Mueller C, Balzer K. Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft. Vascular. 2013 Jun;21(3):137-47. doi: 10.1177/1708538113478773.'}, {'pmid': '19698298', 'type': 'BACKGROUND', 'citation': 'Zegelman M, Guenther G, Florek HJ, Orend KH, Zuehlke H, Liewald F, Storck M. Results from the first in man german pilot study of the silver graft, a vascular graft impregnated with metallic silver. Vascular. 2009 Jul-Aug;17(4):190-6. doi: 10.2310/6670.2009.00034.'}]}, 'descriptionModule': {'briefSummary': 'This web based e-Registry will be international, multi-center and prospective. Silver Graft e-Registry to assess the long term clinical benefit of Silver Graft in an unselected patient population', 'detailedDescription': 'To assess the long term clinical benefit of Silver Graft in an unselected patient population with Peripheral Artery Occlusive Disease (PAOD) fulfilling one of the the following criteria:\n\n1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.\n\n or\n2. Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include\n\n * diabetics\n * Fontaine class\\> IIb\n * patients of advanced age (≥75 y)\n * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)\n * patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)\n * patients with major amputation\n * immunosuppressed patients\n * patients with autoimmune disease, malignancy\n\n or\n3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with PAOD Fontaine classification \\> IIa Patients in need of aneurysm repair Patients in need of revisions, i.e. graft infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any suitable patient in need of an infrarenal vascular reconstruction with Fontaine class IIb or indicated vascular reconstruction aneurysm repair.\n2. Any suitable patient with an increased risk for early graft failure except those mentioned under (3). These may include\n\n * diabetics\n * Fontaine class\\> IIb\n * patients of advanced age (≥75 y)\n * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l)\n * patients with COPD or documented coronary artery disease (prior PCI, prior CABG, documented myocardial ischemia)\n * patients with major amputation\n * immunosuppressed patients\n * patients with autoimmune disease, malignancy\n3. Any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.\n\nExclusion Criteria:\n\n* Any patient with common contraindications for vascular surgery may not be included in this registry.\n* Any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry.\n* Any patient with a known and documented allergy to silver or silver ions.'}, 'identificationModule': {'nctId': 'NCT01970605', 'briefTitle': 'Silver Graft All Comers Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'Silver Graft All Comers Registry is to Assess the Long Term Clinical Benefit of Silver Graft in an Unselected Patient Population', 'orgStudyIdInfo': {'id': 'AAG-O-H-1310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with PAOD or aneurysms', 'description': 'Patients\n\n* in Fontaine class \\> IIa,\n* in need of aneurysm repair,\n* with defined cardiovascular risk factors or\n* graft infections.\n\nSurgical reconstruction with defined Silver Graft vascular prosthesis.', 'interventionNames': ['Procedure: Surgical reconstruction']}], 'interventions': [{'name': 'Surgical reconstruction', 'type': 'PROCEDURE', 'otherNames': ['Vascular reconstruction', 'Vascular prosthesis', 'Silver Graft'], 'description': "In contrast to silver acetate impregnated vascular graft, Silver Graft can be immersed in an antibiotic containing solution prior to implantation. This practice should always be followed according to each participant's hospital guidelines and experience. The long term efficacy of the metallic silver coating will not be reduced.\n\nCommon practice antibiotic co-medication before, during and after surgery needs to be documented but is at the discretion of each participating institution.\n\nDue to the registry character of this assessment, i.e. routine use of the investigational product, local antibiotics, e.g. dipping of the vascular graft into a rifampin solution is permissible.", 'armGroupLabels': ['Patients with PAOD or aneurysms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39130', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Klinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Jörg Tautenhahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Magdeburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}