VIVO Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01970007
First received: October 22, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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
stenting
Other Name: venous stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01970007

Contacts
Contact: Leslie Rooze, MS, CCRP 765-463-7537 lrooze@medinst.com

  Show 21 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Anthony J. Comerota, MD, FACS, FACC Jobst Vascular Institute
Principal Investigator: Lawrence "Rusty" Hofmann, MD Stanford University
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01970007     History of Changes
Other Study ID Numbers: 11-010
Study First Received: October 22, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
venous
outflow obstruction
iliofemoral vein

ClinicalTrials.gov processed this record on September 30, 2014