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CompletedNCT01663051VIVO EUUpdated Nov 1, 2016

Evaluation of the Zilver® Vena™ Venous Stent

An observational study in Iliofemoral Venous Outflow Obstruction, sponsored by Cook Group Incorporated. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Cook Group Incorporated · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Iliofemoral Venous Outflow Obstruction
03

In context

Lead sponsor

Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)

Groups and cohorts

  • Stent

    Stent

    Device: Zilver Vena Venous Stent

Interventions

  • DeviceZilver Vena Venous Stent

    Stenting iliofemoral venous outflow obstruction

06

What researchers measure

Primary outcomes

  1. Major Adverse Events

    Time frame: 1 month

  2. Patency

    Assessed via ultrasound

    Time frame: 12 months

07

Study locations

5 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 25541444 ↗
  • 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. PubMed 23558660 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01663051
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Aug 13, 2012
Start date
Nov 2012
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Nov 1, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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