Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 11:05 AM
Study NCT ID:
NCT01663051
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2012-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Zilver® Vena™ Venous Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Events', 'timeFrame': '1 month'}, {'measure': 'Patency', 'timeFrame': '12 months', 'description': 'Assessed via ultrasound'}]}, 'conditionsModule': {'conditions': ['Iliofemoral Venous Outflow Obstruction']}, 'referencesModule': {'references': [{'pmid': '25541444', 'type': 'DERIVED', 'citation': "O'Sullivan GJ, Waldron D, Mannion E, Keane M, Donnellan PP. Thrombolysis and iliofemoral vein stent placement in cancer patients with lower extremity swelling attributed to lymphedema. J Vasc Interv Radiol. 2015 Jan;26(1):39-45. doi: 10.1016/j.jvir.2014.10.010."}, {'pmid': '23558660', 'type': 'DERIVED', 'citation': "O'Sullivan GJ, Sheehan J, Lohan D, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. J Cardiovasc Surg (Torino). 2013 Apr;54(2):255-61."}]}, 'descriptionModule': {'briefSummary': 'This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic iliofemoral venous outflow obstruction.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by:\n* CEAP 'C' ≥ 3, or\n* VCSS pain score ≥ 2\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* Pregnant or planning to become pregnant in the next 12 months\n* Planned surgical or interventional procedures (except thrombolysis and thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or after the study procedure.\n* Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter\n* Previous stenting of the target vessel\n* Iliofemoral venous segment unsuitable for treatment with available sizes of study devices"}, 'identificationModule': {'nctId': 'NCT01663051', 'acronym': 'VIVO EU', 'briefTitle': 'Evaluation of the Zilver® Vena™ Venous Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Evaluation of the Zilver® Vena™ Venous Stent', 'orgStudyIdInfo': {'id': '10-018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stent', 'description': 'Stent', 'interventionNames': ['Device: Zilver Vena Venous Stent']}], 'interventions': [{'name': 'Zilver Vena Venous Stent', 'type': 'DEVICE', 'description': 'Stenting iliofemoral venous outflow obstruction', 'armGroupLabels': ['Stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Arnsberg GmbH', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospitals', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Madrid Monteprincipe', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8401', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}