Evaluation of the Zilver® Vena™ Venous Stent
Completed
- Conditions
- Iliofemoral Venous Outflow Obstruction
- Interventions
- Device: Zilver Vena Venous Stent
- Registration Number
- NCT01663051
- Lead Sponsor
- Cook Group Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stent Zilver Vena Venous Stent Stent
- Primary Outcome Measures
Name Time Method Major Adverse Events 1 month Patency 12 months Assessed via ultrasound
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Hospital Madrid Monteprincipe
🇪🇸Madrid, Spain
Klinikum Arnsberg GmbH
🇩🇪Arnsberg, Germany
Galway University Hospitals
🇮🇪Galway, Ireland
Guy's and St Thomas' Hospital
🇬🇧London, United Kingdom
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland