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

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.

Study Overview

• Status: Withdrawn
• Conditions: Venous Vascular Diseases and Syndromes
• Intervention / Treatment: Device: Sinus-Venous stent (Optimed GmbH)

• Study Type: Observational

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with venous iliofemoral occlusive disease.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent patency	Patency broken down in primary patency, assisted primary patency and secondary patency	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		12 months
Technical success	The index-procedure is the endovascular procedure in which the patient receives the device.	Index-procedure (intraoperative)
Revised venous clinical severity score		12 months
Procedural complications		Index-procedure
Reintervention	Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment	12 months

Collaborators and Investigators

• Sponsor: be Medical
• Collaborators: Archer Research
• Investigators: Principal Investigator: Geert Lauwers, MD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (ESTIMATE): June 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: VS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO