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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01663051
First received: August 6, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Estimated Enrollment: 35
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stent
Stent
Device: Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01663051

Contacts
Contact: Ashley Hughes, MS 765-463-7537 ahughes@medinst.com
Contact: Lars Stage +45 56868686 lars.stage@cookmedical.com

Locations
Denmark
Gentofte Hospital Withdrawn
Gentofte, Denmark, 2900
Germany
Klinikum Arnsberg GmbH Not yet recruiting
Arnsberg, Germany
Contact: Michael Lichtenberg, Dr. Med       M.Lichtenberg@klinikum-arnsberg.de   
Ireland
Galway University Hospitals Recruiting
Galway, Ireland
Contact: Gerard O'Sullivan, Dr. Med    +35 3 915 423 56    Gerard.osullivan2@hse.ie   
Spain
Hospital Madrid Monteprincipe Recruiting
Madrid, Spain
Contact: Marta R. Ortega, Dr. Med    +34 61 92 07 922    pgusanian@gmail.com   
Switzerland
Kantonsspital Winterthur Not yet recruiting
Winterthur, Switzerland, 8401
Contact: Christoph Binkert       christoph.binkert@ksw.ch   
United Kingdom
Guy's and St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Narayan Karunanithy       narayan.karunanithy@kcl.ac.uk   
Sponsors and Collaborators
Cook
  More Information

No publications provided by Cook

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01663051     History of Changes
Other Study ID Numbers: 10-018
Study First Received: August 6, 2012
Last Updated: August 4, 2014
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

ClinicalTrials.gov processed this record on September 30, 2014