Skip to main content
OpenTrials
Completed

NCT Number: NCT01663051

Evaluation of the Zilver® Vena™ Venous Stent

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iliofemoral Venous Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Arnsberg GmbH, Arnsberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zilver Vena Venous Stent

Device

Stenting iliofemoral venous outflow obstruction

Primary outcomes

  1. Major Adverse Events

    Time frame: 1 month

  2. Patency

    Time frame: 12 months

    Assessed via ultrasound

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Acronym: VIVO EU

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.