Study Results
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View full resultsBasic Information
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COMPLETED
NA
243 participants
INTERVENTIONAL
2013-12-13
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zilver Vena Venous Self-Expanding Stent
Zilver Vena Venous Self-Expanding Stent
stenting
Interventions
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Zilver Vena Venous Self-Expanding Stent
stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CEAP "C" ≥ 3, or
* VCSS pain score ≥ 2
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cook Research Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony J. Comerota, MD, FACS, FACC
Role: PRINCIPAL_INVESTIGATOR
Inova Vascular
Lawrence "Rusty" Hofmann, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
Arrowhead Hospital
Glendale, Arizona, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Southern Connecticut Vascular Center - Norwalk Hospital
Norwalk, Connecticut, United States
Christiana Care Health Systems
Newark, Delaware, United States
Florida Pepin Heart Institute
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Louisville - Norton Hospital
Louisville, Kentucky, United States
Shady Grove Adventist
Rockville, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Barnes Jewish Hospital Plaza
St Louis, Missouri, United States
Mercy Hospital
St Louis, Missouri, United States
CHI Health St. Elizabeth
Lincoln, Nebraska, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
New York University - Langone Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Rex Hospital
Raleigh, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
ProMedica - Jobst Vascular Institute
Toledo, Ohio, United States
Oklahoma State University Medical Center
Tulsa, Oklahoma, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Taipei Medical University Wan Fang Hospital
Taipei, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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11-010
Identifier Type: -
Identifier Source: org_study_id
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