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VIVO Clinical Study

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.
 
ClinicalTrials.gov Identifier: NCT01970007
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Description
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Brief Summary:
The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Condition or disease Intervention/treatment Phase
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein Device: Zilver Vena Venous Stent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
Study Start Date : December 12, 2013
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 12, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Zilver Vena Venous Stent Device: Zilver Vena Venous Stent
stenting
Other Name: venous stent


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from major adverse events [ Time Frame: 30 days ]
  2. Primary patency [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in VCSS [ Time Frame: 1 month ]
  2. Change in VCSS [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, 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 of the target limb (except thrombolysis and/or 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 any time after the study procedure;
  • planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) 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;
  • lesion with malignant obstruction;
  • previous stenting of the target vessel;
  • iliofemoral venous segment unsuitable for treatment with available sizes of study devices.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970007


Locations
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Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Anthony J. Comerota, MD, FACS, FACC Jobst Vascular Institute
Principal Investigator: Lawrence "Rusty" Hofmann, MD Stanford University
More Information
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT01970007    
Other Study ID Numbers: 11-010
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
venous
outflow obstruction
iliofemoral vein