Venous Vascular Diseases and SyndromesNCT02799914
Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease
An observational study of Venous Vascular Diseases and Syndromes, run by be Medical at 1 site in Belgium.
Trial summary
Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Vascular Diseases and Syndromes
- What is being tested?
- Sinus-Venous stent (Optimed GmbH)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Jun 2018
- 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 venous iliofemoral occlusive disease.
Who may be able to join
- Age at study entry is at least 18 years.
- Patient must sign the informed consent form prior to the index-procedure.
- Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
- Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.
Who cannot join
- Intolerance to anticoagulant medication.
- Contra-indication for prolonged anticoagulant treatment.
- Life expectancy less than 1 year.
- Target vessel has been stented before.
- Coagulopathy or known uncorrectable bleeding diathesis.
- Recent (<1 year) pulmonary embolism.
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- Pregnancy.
- Known hypersensitivity to nitinol and/or nickel.
- Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
- Patients in custody by juridical order.
- Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
- Close affiliation with the investigational site: e.g. a close relative of the investigator or a possibly dependent person (e.g. employee or student of the investigational site).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease: A Monocenter Post Market Clinical Follow-up Study
Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.
- Conditions
- Venous Vascular Diseases and Syndromes
- Being tested
- Sinus-Venous stent (Optimed GmbH)
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus-Venous stent (Optimed GmbH)Device
Stent implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency
Patency broken down in primary patency, assisted primary patency and secondary patency
Measured: 12 months
Secondary outcomes (5)
Technical success
The index-procedure is the endovascular procedure in which the patient receives the device.
Measured: Index-procedure (intraoperative)
Revised venous clinical severity score
Measured: 12 months
Mortality
Measured: 12 months
Procedural complications
Measured: Index-procedure
Reintervention
Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment
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 posted15 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Difficult patient recruitment. No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Vascular Diseases and SyndromesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
- Investigators
- Geert Lauwers, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799914
- Sponsor's protocol ID
- VS-01
- Status last verified
- Nov 2017
- First submitted
- 7 Dec 2015
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease: A Monocenter Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT02799914
- Acronym / sponsor ID
- VS-01
- Conditions
- Venous Vascular Diseases and Syndromes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficult patient recruitment. No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Jun 2016 (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.
Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with venous iliofemoral occlusive disease.
Key inclusion criteria (4 listed)
- Age at study entry is at least 18 years.
- Patient must sign the informed consent form prior to the index-procedure.
- Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
- Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.
Key exclusion criteria (13 listed)
- Intolerance to anticoagulant medication.
- Contra-indication for prolonged anticoagulant treatment.
- Life expectancy less than 1 year.
- Target vessel has been stented before.
- Coagulopathy or known uncorrectable bleeding diathesis.
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 |
|---|---|---|
| Sinus-Venous stent (Optimed GmbH)Stent implantation | Device | – |
Primary outcome
Stent patency
Time frame: 12 months
Patency broken down in primary patency, assisted primary patency and secondary patency
5 secondary outcomes
Technical success
Time frame: Index-procedure (intraoperative)
Revised venous clinical severity score
Time frame: 12 months
Mortality
Time frame: 12 months
Procedural complications
Time frame: Index-procedure
Reintervention
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Geert Lauwers, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Vascular Diseases and Syndromes, run by be Medical at 1 site in Belgium.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Stent patency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019.