VIVO Clinical Study
Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
1 other identifier
interventional
243
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedStudy Start
First participant enrolled
December 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedResults Posted
Study results publicly available
April 8, 2021
CompletedApril 8, 2021
March 1, 2021
3.9 years
October 22, 2013
February 3, 2021
March 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
Baseline and 1 month
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
Baseline and 12 months
Study Arms (1)
Zilver Vena Venous Self-Expanding Stent
EXPERIMENTALInterventions
stenting
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \< 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233, United States
Arrowhead Hospital
Glendale, Arizona, 85308, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Southern Connecticut Vascular Center - Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Christiana Care Health Systems
Newark, Delaware, 19718, United States
Florida Pepin Heart Institute
Tampa, Florida, 33613, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
St. Vincent Medical Group
Indianapolis, Indiana, 46290, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Louisville - Norton Hospital
Louisville, Kentucky, 40202, United States
Shady Grove Adventist
Rockville, Maryland, 20850, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Barnes Jewish Hospital Plaza
St Louis, Missouri, 63110, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
CHI Health St. Elizabeth
Lincoln, Nebraska, 68510, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
New York University - Langone Medical Center
New York, New York, 10016, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Rex Hospital
Raleigh, North Carolina, 27607, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
ProMedica - Jobst Vascular Institute
Toledo, Ohio, 43606, United States
Oklahoma State University Medical Center
Tulsa, Oklahoma, 74127, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Taipei Medical University Wan Fang Hospital
Taipei, 116, Taiwan
Related Publications (1)
Hofmann LR, Gagne P, Brown JA, Saunders A, Comerota A; VIVO Study Investigators. Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study). J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):532-541.e4. doi: 10.1016/j.jvsv.2022.12.066. Epub 2023 Jan 13.
PMID: 36646383DERIVED
Results Point of Contact
- Title
- Alan Saunders, MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony J. Comerota, MD, FACS, FACC
Inova Vascular
- PRINCIPAL INVESTIGATOR
Lawrence "Rusty" Hofmann, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
December 13, 2013
Primary Completion
November 20, 2017
Study Completion
November 20, 2019
Last Updated
April 8, 2021
Results First Posted
April 8, 2021
Record last verified: 2021-03