NCT01663051|Completed
Evaluation of the Zilver® Vena™ Venous Stent
VIVO EU
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VIVO EU
Sponsor study identifier
observational
35
5 countries
5
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2012
Actual (reported)August 13, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2016
Actual (reported)July 2016
Actual (reported)Major Adverse Events
1 month
Patency
Assessed via ultrasound
12 months
Stent
Stenting iliofemoral venous outflow obstruction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with symptomatic iliofemoral venous outflow obstruction.
Klinikum Arnsberg GmbH
Arnsberg, Germany
Galway University Hospitals
Galway, Ireland
Hospital Madrid Monteprincipe
Madrid, Spain
Kantonsspital Winterthur
Winterthur, 8401, Switzerland
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
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.
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.
35 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2012
First Posted
August 13, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2016
Actual (reported)Study Completion
July 2016
Actual (reported)Last Updated
November 1, 2016
Record last verified: 2016-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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