Iliofemoral Venous Outflow ObstructionVIVO EUNCT01663051
Evaluation of the Zilver® Vena™ Venous Stent
An observational study of Iliofemoral Venous Outflow Obstruction, run by Cook Group Incorporated at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliofemoral Venous Outflow Obstruction
- What is being tested?
- Zilver Vena Venous Stent
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Nov 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic iliofemoral venous outflow obstruction.
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
- Conditions
- Iliofemoral Venous Outflow Obstruction
- Being tested
- Zilver Vena Venous Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilver Vena Venous StentDevice
Stenting iliofemoral venous outflow obstruction
| Study group | Role | What they receive |
|---|---|---|
| Stent | Stent Receives: Device: Zilver Vena Venous Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
Measured: 1 month
Patency
Assessed via ultrasound
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iliofemoral Venous Outflow ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663051
- Sponsor's protocol ID
- 10-018
- Acronym
- VIVO EU
- Status last verified
- Oct 2016
- First submitted
- 6 Aug 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
Publications
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.
PubMed 25541444O'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.
PubMed 23558660
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Zilver® Vena™ Venous Stent
- ClinicalTrials.gov ID
- NCT01663051
- Acronym / sponsor ID
- VIVO EU / 10-018
- Conditions
- Iliofemoral Venous Outflow Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent | – | Device: Zilver Vena Venous StentStent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic iliofemoral venous outflow obstruction.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zilver Vena Venous StentStenting iliofemoral venous outflow obstruction | Device | Stent |
Primary outcome
Major Adverse Events
Time frame: 1 month
Patency
Time frame: 12 months
Assessed via ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 25541444O'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.
- Derived from this study: PubMed 23558660O'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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliofemoral Venous Outflow Obstruction, run by Cook Group Incorporated at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Ireland, Spain, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01663051, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.