VIVO Clinical Study

Not Applicable

Completed

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.

Recruitment & Eligibility

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 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)

Locations (30): 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
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University of Alabama Birmingham Hospital
🇺🇸Birmingham, Alabama, United States