Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2012-11-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stent
Stent
Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction
Interventions
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Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction
Eligibility Criteria
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Inclusion Criteria
* CEAP 'C' ≥ 3, or
* VCSS pain score ≥ 2
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Locations
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Klinikum Arnsberg GmbH
Arnsberg, , Germany
Galway University Hospitals
Galway, , Ireland
Hospital Madrid Monteprincipe
Madrid, , Spain
Kantonsspital Winterthur
Winterthur, , Switzerland
Guy's and St Thomas' Hospital
London, , United Kingdom
Countries
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References
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O'Sullivan GJ, Waldron D, Mannion E, Keane M, Donnellan PP. Thrombolysis and iliofemoral vein stent placement in cancer patients with lower extremity swelling attributed to lymphedema. J Vasc Interv Radiol. 2015 Jan;26(1):39-45. doi: 10.1016/j.jvir.2014.10.010.
O'Sullivan GJ, Sheehan J, Lohan D, McCann-Brown JA. Iliofemoral venous stenting extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena stent. J Cardiovasc Surg (Torino). 2013 Apr;54(2):255-61.
Other Identifiers
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10-018
Identifier Type: -
Identifier Source: org_study_id