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

Withdrawn

• Conditions: Venous Vascular Diseases and Syndromes

• Registration Number: NCT02799914
• Lead Sponsor: be Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-07
• Study Start: 2016-04
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Status Verified: 2017-11
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent patency	12 months	Patency broken down in primary patency, assisted primary patency and secondary patency

Secondary Outcome Measures

Name	Time	Method
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
Reintervention	12 months	Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment
Procedural complications	Index-procedure

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium