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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cook Identifier:
First received: August 6, 2012
Last updated: January 29, 2016
Last verified: December 2015
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 Intervention
Iliofemoral Venous Outflow Obstruction
Device: Zilver Vena Venous Stent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Zilver® Vena™ Venous Stent

Further study details as provided by Cook:

Primary Outcome Measures:
  • Major Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessed via ultrasound

Enrollment: 35
Study Start Date: November 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Device: Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01663051

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cook Identifier: NCT01663051     History of Changes
Other Study ID Numbers: 10-018 
Study First Received: August 6, 2012
Last Updated: January 29, 2016
Health Authority: Denmark: Ethics Committee
Spain: Ethics Committee
Italy: Ethics Committee
Ireland: Research Ethics Committee
Germany: Ethics Commission
United Kingdom: Research Ethics Committee
Switzerland: Ethikkommission processed this record on October 26, 2016