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. Identifier: NCT01970007
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

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 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 : October 2013
Actual Primary Completion Date : November 20, 2017
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Zilver Vena Venous Stent Device: Zilver Vena Venous Stent
Other Name: venous stent

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 ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01970007

  Show 30 Study Locations
Sponsors and Collaborators
Cook Group Incorporated
Principal Investigator: Anthony J. Comerota, MD, FACS, FACC Jobst Vascular Institute
Principal Investigator: Lawrence "Rusty" Hofmann, MD Stanford University

Responsible Party: Cook Group Incorporated Identifier: NCT01970007     History of Changes
Other Study ID Numbers: 11-010
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Cook Group Incorporated:
outflow obstruction
iliofemoral vein