Evaluation of the Zilver® Vena™ Venous Stent (VIVO EU)
This study is currently recruiting participants.
Verified November 2012 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01663051
First received: August 6, 2012
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
| Condition | Intervention |
|---|---|
|
Iliofemoral Venous Outflow Obstruction |
Device: Zilver Vena Venous Stent |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of the Zilver® Vena™ Venous Stent |
Further study details as provided by Cook:
Primary Outcome Measures:
- Major Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]Assessed via ultrasound
| Estimated Enrollment: | 35 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Stent
Stent
|
Device: Zilver Vena Venous Stent
Stenting iliofemoral venous outflow obstruction
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with symptomatic iliofemoral venous outflow obstruction.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663051
Contacts
| Contact: Ashley Hughes, MS | 765-463-7537 | ahughes@medinst.com |
| Contact: Lars Stage | +45 56868686 | lars.stage@cookmedical.com |
Locations
| Denmark | |
| Gentofte Hospital | Recruiting |
| Gentofte, Denmark, 2900 | |
| Contact: Niels Baekgaard, Assoc. Prof. +45 3977 7508 nibae@geh.regionh.dk | |
| Ireland | |
| Galway University Hospitals | Recruiting |
| Galway, Ireland | |
| Contact: Gerard O'Sullivan, Dr. Med +35 3 915 423 56 Gerard.osullivan2@hse.ie | |
| Spain | |
| Hospital Madrid Monteprincipe | Recruiting |
| Madrid, Spain | |
| Contact: Marta R. Ortega, Dr. Med +34 61 92 07 922 pgusanian@gmail.com | |
Sponsors and Collaborators
Cook
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT01663051 History of Changes |
| Other Study ID Numbers: | 10-018 |
| Study First Received: | August 6, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | Denmark: Ethics Committee Spain: Ethics Committee Italy: Ethics Committee Ireland: Research Ethics Committee |
ClinicalTrials.gov processed this record on May 16, 2013