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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01663051
First received: August 6, 2012
Last updated: February 12, 2014
Last verified: February 2014

August 6, 2012
February 12, 2014
November 2012
June 2015   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01663051 on ClinicalTrials.gov Archive Site
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Evaluation of the Zilver® Vena™ Venous Stent
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with symptomatic iliofemoral venous outflow obstruction.

Iliofemoral Venous Outflow Obstruction
Device: Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction
Stent
Stent
Intervention: Device: Zilver Vena Venous Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ashley Hughes, MS 765-463-7537 ahughes@medinst.com
Contact: Lars Stage +45 56868686 lars.stage@cookmedical.com
Denmark,   Ireland,   Spain,   Switzerland,   United Kingdom
 
NCT01663051
10-018
Not Provided
Cook
Cook
Not Provided
Not Provided
Cook
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP