VIVO Clinical Study

Completed · Not applicable

Conditions studied: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein

In brief

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.

Key facts

Study ID

NCT01970007

Run by

Cook Research Incorporated

People needed

243

Starts

2013-12-13

Expected to finish

2019-11-20

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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