Venous Vascular Diseases and Syndromes
Conditions
Brief 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.
Interventions
DEVICESinus-Venous stent (Optimed GmbH)
Stent implantation
Sponsors
Archer Research
be Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent patency | 12 months | Patency broken down in primary patency, assisted primary patency and secondary patency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Index-procedure (intraoperative) | The index-procedure is the endovascular procedure in which the patient receives the device. |
| Revised venous clinical severity score | 12 months | — |
| Mortality | 12 months | — |
| Procedural complications | Index-procedure | — |
| Reintervention | 12 months | Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment |
Countries
Belgium
Outcome results
None listed