NCT01663051

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

August 6, 2012

Last Update Submit

October 31, 2016

Conditions

Iliofemoral Venous Outflow Obstruction

Outcome Measures

Primary Outcomes (2)

  • Major Adverse Events

    1 month

  • Patency

    Assessed via ultrasound

    12 months

Study Arms (1)

Stent

Stent

Device: Zilver Vena Venous Stent

Interventions

Zilver Vena Venous StentDEVICE

Stenting iliofemoral venous outflow obstruction

Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic iliofemoral venous outflow obstruction.

You may qualify if:

  • 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Arnsberg GmbH

Arnsberg, Germany

Location

Galway University Hospitals

Galway, Ireland

Location

Hospital Madrid Monteprincipe

Madrid, Spain

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Guy's and St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 25541444DERIVED

  • 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.

    PMID: 23558660DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 13, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

DE(1)IE(1)GB(1)CH(1)ES(1)