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

NCT02799914 | Withdrawn

• 1 other identifier: VS-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Vascular Diseases and Syndromes

Outcome Measures

Primary Outcomes (1)

• Stent patency

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

  12 months

Secondary Outcomes (5)

• Technical success

  Index-procedure (intraoperative)

• Revised venous clinical severity score

  12 months

• Mortality

  12 months

• Procedural complications

  Index-procedure

• Reintervention

  12 months

Interventions

Sinus-Venous stent (Optimed GmbH) DEVICE

Stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with venous iliofemoral occlusive disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• be Medical: lead
• Archer Research: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Syndrome

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Geert Lauwers, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: June 15, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)