VIVO Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Cook
Information provided by (Responsible Party):
Cook Identifier:
First received: October 22, 2013
Last updated: March 18, 2016
Last verified: December 2015
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 Intervention
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Device: Zilver Vena Venous Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in VCSS [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change in VCSS [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 243
Study Start Date: October 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zilver Vena Venous Stent Device: Zilver Vena Venous Stent
Other Name: venous stent


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01970007

Contact: Leslie Rooze, MS, CCRP 765-463-7537

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

Responsible Party: Cook Identifier: NCT01970007     History of Changes
Other Study ID Numbers: 11-010 
Study First Received: October 22, 2013
Last Updated: March 18, 2016
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by Cook:
outflow obstruction
iliofemoral vein processed this record on May 03, 2016