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WithdrawnNCT02799914Updated Feb 8, 2019

Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease

An observational study in Venous Vascular Diseases and Syndromes, sponsored by be Medical. Withdrawn at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by be Medical · Observational

Why this study was withdrawn
Difficult patient recruitment. No patients enrolled.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Venous Vascular Diseases and Syndromes

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03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

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Lead sponsor

be Medical is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with venous iliofemoral occlusive disease.

Inclusion criteria

  1. Age at study entry is at least 18 years.
  2. Patient must sign the informed consent form prior to the index-procedure.
  3. Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
  4. Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.

Exclusion criteria

Exclusion Criteria:

  1. Intolerance to anticoagulant medication.
  2. Contra-indication for prolonged anticoagulant treatment.
  3. Life expectancy less than 1 year.
  4. Target vessel has been stented before.
  5. Coagulopathy or known uncorrectable bleeding diathesis.
  6. Recent (\<1 year) pulmonary embolism.
  7. Pregnancy.
  8. Known hypersensitivity to nitinol and/or nickel.
  9. 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).
  10. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
  11. Patients in custody by juridical order.
  12. Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
  13. 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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DeviceSinus-Venous stent (Optimed GmbH)

    Stent implantation

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What researchers measure

Primary outcomes

  1. Stent patency

    Patency broken down in primary patency, assisted primary patency and secondary patency

    Time frame: 12 months

Secondary outcomes

  1. Technical success

    The index-procedure is the endovascular procedure in which the patient receives the device.

    Time frame: Index-procedure (intraoperative)

  2. Revised venous clinical severity score

    Time frame: 12 months

  3. Mortality

    Time frame: 12 months

  4. Procedural complications

    Time frame: Index-procedure

  5. Reintervention

    Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment

    Time frame: 12 months

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Study locations

1 site
  • Ziekenhuis Oost-Limburg
    Genk, 3600, Belgium
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02799914
Lead sponsor
be Medical
Collaborators
Archer Research
Responsible party
Sponsor
First posted
Jun 15, 2016
Start date
Apr 2016
Primary completion
Jun 2018
Completion
Jun 2018
Last update
Feb 8, 2019

Study contacts

Geert Lauwers, MD
principal investigator · Ziekenhuis Oost-Limburg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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