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Evaluation of the Zilver® Vena™ Venous Stent (VIVO EU)

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ClinicalTrials.gov Identifier: NCT01663051
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Condition or disease Intervention/treatment
Iliofemoral Venous Outflow Obstruction Device: Zilver Vena Venous Stent

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Zilver® Vena™ Venous Stent
Study Start Date : November 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Group/Cohort Intervention/treatment
Stent
Stent
Device: Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction



Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: 1 month ]
  2. Patency [ Time Frame: 12 months ]
    Assessed via ultrasound



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic iliofemoral venous outflow obstruction.
Criteria

Inclusion Criteria:

  • Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by:
  • CEAP 'C' ≥ 3, or
  • VCSS pain score ≥ 2

Exclusion Criteria:

  • < 18 years of age
  • Pregnant or planning to become pregnant in the next 12 months
  • 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.
  • Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter
  • Previous stenting of the target vessel
  • Iliofemoral venous segment unsuitable for treatment with available sizes of study devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663051


Locations
Germany
Klinikum Arnsberg GmbH
Arnsberg, Germany
Ireland
Galway University Hospitals
Galway, Ireland
Spain
Hospital Madrid Monteprincipe
Madrid, Spain
Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
United Kingdom
Guy's and St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Cook Group Incorporated