Evaluation of the Zilver® Vena™ Venous Stent

Iliofemoral Venous Outflow Obstruction Clinical Trial

— VIVO EU  

Official title:

Evaluation of the Zilver® Vena™ Venous Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663051
• Other study ID #: 10-018
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: October 31, 2016
• Start date: November 2012
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeSpain: Ethics CommitteeItaly: Ethics CommitteeIreland: Research Ethics CommitteeGermany: Ethics CommissionUnited Kingdom: Research Ethics CommitteeSwitzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Iliofemoral Venous Outflow Obstruction

Intervention

Device:
• Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction

Locations

Country	Name	City	State
Germany	Klinikum Arnsberg GmbH	Arnsberg
Ireland	Galway University Hospitals	Galway
Spain	Hospital Madrid Monteprincipe	Madrid
Switzerland	Kantonsspital Winterthur	Winterthur
United Kingdom	Guy's and St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Countries where clinical trial is conducted

Germany,  Ireland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events		1 month	Yes
Primary	Patency	Assessed via ultrasound	12 months	No