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

BE Medical

Status: Withdrawn

Conditions: Venous Vascular Diseases and Syndromes

Treatments: Device: Sinus-Venous stent (Optimed GmbH)

Study type: Observational

Funder types: Industry

Identifiers

NCT02799914

VS-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).