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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01663051
First received: August 6, 2012
Last updated: January 29, 2016
Last verified: December 2015

August 6, 2012
January 29, 2016
November 2012
September 2016   (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.
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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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
September 2016
September 2016   (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 information is only displayed when the study is recruiting subjects
Germany,   Ireland,   Spain,   Switzerland,   United Kingdom
Denmark
 
NCT01663051
10-018
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Cook
Cook
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Not Provided
Cook
December 2015

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