VIVO Clinical Study
- Conditions
- Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
- Interventions
- Device: Zilver Vena Venous Self-Expanding Stent
- Registration Number
- NCT01970007
- Lead Sponsor
- Cook Research Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
-
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
- < 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zilver Vena Venous Self-Expanding Stent Zilver Vena Venous Self-Expanding Stent -
- Primary Outcome Measures
Name Time Method The Rate of Participants With Primary Quantitative Patency at 12 Months 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.
Number of Participants With 30-day Freedom From Major Adverse Events 30 days 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month Baseline and 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)Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months Baseline and 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)
Trial Locations
- Locations (30)
Littleton Adventist Hospital
🇺🇸Littleton, Colorado, United States
University of Louisville - Norton Hospital
🇺🇸Louisville, Kentucky, United States
Southern Connecticut Vascular Center - Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Arrowhead Hospital
🇺🇸Glendale, Arizona, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
University of Alabama Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Oklahoma State University Medical Center
🇺🇸Tulsa, Oklahoma, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
ProMedica - Jobst Vascular Institute
🇺🇸Toledo, Ohio, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Florida Pepin Heart Institute
🇺🇸Tampa, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CHI Health St. Elizabeth
🇺🇸Lincoln, Nebraska, United States
Methodist Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Utah Valley Regional Medical Center
🇺🇸Provo, Utah, United States
Taipei Medical University Wan Fang Hospital
🇨🇳Taipei, Taiwan
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Christiana Care Health Systems
🇺🇸Newark, Delaware, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Barnes Jewish Hospital Plaza
🇺🇸Saint Louis, Missouri, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
New York University - Langone Medical Center
🇺🇸New York, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cardiothoracic and Vascular Surgeons
🇺🇸Austin, Texas, United States
Shady Grove Adventist
🇺🇸Rockville, Maryland, United States