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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663051
First Posted: August 13, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated
August 6, 2012
August 13, 2012
November 1, 2016
November 2012
July 2016   (Final data collection date for primary outcome measure)
  • Major Adverse Events [ Time Frame: 1 month ]
  • Patency [ Time Frame: 12 months ]
    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.
 
Completed
35
July 2016
July 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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 Group Incorporated
Cook Group Incorporated
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Not Provided
Cook Group Incorporated
October 2016