Iliofemoral Venous Outflow Obstruction
Conditions
Brief summary
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Interventions
DEVICEZilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction
Sponsors
Cook Group Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by: * CEAP 'C' ≥ 3, or * VCSS pain score ≥ 2
Exclusion criteria
* \< 18 years of age * Pregnant or planning to become pregnant in the next 12 months * Planned surgical or interventional procedures (except thrombolysis and 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 after the study procedure. * Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter * Previous stenting of the target vessel * Iliofemoral venous segment unsuitable for treatment with available sizes of study devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 1 month | — |
| Patency | 12 months | Assessed via ultrasound |
Countries
Germany, Ireland, Spain, Switzerland, United Kingdom
Outcome results
None listed