Clinical trial NCT01970007: VIVO Clinical Study
Official title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Keywords: venous
outflow obstruction
iliofemoral vein
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

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.

Primary outcomes:
measure: Number of Participants With 30-day Freedom From Major Adverse Events
timeFrame: 30 days
measure: The Rate of Participants With Primary Quantitative Patency at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
timeFrame: Baseline and 1 month
measure: Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Hospital
state: Alabama
city: Glendale
country: United States
facility: Arrowhead Hospital
state: Arizona
city: Littleton
country: United States
facility: Littleton Adventist Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Norwalk
country: United States
facility: Southern Connecticut Vascular Center - Norwalk Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
city: Tampa
country: United States
facility: Florida Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: University of Louisville - Norton Hospital
state: Kentucky
city: Rockville
country: United States
facility: Shady Grove Adventist
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital Plaza
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Lincoln
country: United States
facility: CHI Health St. Elizabeth
state: Nebraska
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University - Langone Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Toledo
country: United States
facility: ProMedica - Jobst Vascular Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University Medical Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Cardiothoracic and Vascular Surgeons
state: Texas
city: Provo
country: United States
facility: Utah Valley Regional Medical Center
state: Utah
city: Taipei
country: Taiwan
facility: Taipei Medical University Wan Fang Hospital
Study officials:
affiliation: Inova Vascular
name: Anthony J. Comerota, MD, FACS, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Lawrence "Rusty" Hofmann, MD
role: PRINCIPAL_INVESTIGATOR
References: