VIVO Clinical Study

Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
• Intervention / Treatment: Device: Zilver Vena Venous Self-Expanding Stent

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University Wan Fang Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham Hospital
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Arrowhead Hospital
  • Colorado
    • Littleton, Colorado, United States, 80122
      • Littleton Adventist Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
    • Norwalk, Connecticut, United States, 06856
      • Southern Connecticut Vascular Center - Norwalk Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Systems
  • Florida
    • Tampa, Florida, United States, 33613
      • Florida Pepin Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital of Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Medical Group
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville - Norton Hospital
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Shady Grove Adventist
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital Plaza
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • CHI Health St. Elizabeth
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University - Langone Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Toledo, Ohio, United States, 43606
      • ProMedica - Jobst Vascular Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons
  • Utah
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Zilver Vena Venous Self-Expanding Stent	Device: Zilver Vena Venous Self-Expanding Stent; stenting; Other Names: venous stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 30-day Freedom From Major Adverse Events	Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.	30 days
The Rate of Participants With Primary Quantitative Patency at 12 Months	Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) > 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month	Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30. Mean change = (1-month score - Baseline Score)	Baseline and 1 month
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months	Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30. Mean change = (12-month score - Baseline Score)	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: Principal Investigator: Anthony J. Comerota, MD, FACS, FACC, Inova Vascular; Principal Investigator: Lawrence "Rusty" Hofmann, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2013
• Primary Completion (ACTUAL): November 20, 2017
• Study Completion (ACTUAL): November 20, 2019

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (ESTIMATE): October 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: venous; iliofemoral vein; outflow obstruction
• Other Study ID Numbers: 11-010