VIVO Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

Conditions
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Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein

Intervention / Treatment
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* Device: Zilver Vena Venous Self-Expanding Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zilver Vena Venous Self-Expanding Stent<br> | Device: Zilver Vena Venous Self-Expanding Stent<br>* stenting<br>* Other names: venous stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 30-day Freedom From Major Adverse Events | 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. | 30 days | 
| The Rate of Participants With Primary Quantitative Patency at 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Venous Clinical Severity Score (VCSS) at 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) | Baseline and 1 month | 
| Change From Baseline in the Venous Clinical Severity Score (VCSS) at 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) | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous, outflow obstruction, iliofemoral vein