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

Venous Vascular Diseases and Syndromes Clinical Trial

Official title:

Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease: A Monocenter Post Market Clinical Follow-up Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02799914
• Other study ID #: VS-01
• Status: Withdrawn
• Start date: April 2016
• Est. completion date: June 2018

Study information

• Verified date: November 2017
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Vascular Diseases
• Venous Vascular Diseases and Syndromes

Intervention

Device:
• Sinus-Venous stent (Optimed GmbH)
Stent implantation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
be Medical	Archer Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent patency	Patency broken down in primary patency, assisted primary patency and secondary patency	12 months
Secondary	Technical success	The index-procedure is the endovascular procedure in which the patient receives the device.	Index-procedure (intraoperative)
Secondary	Revised venous clinical severity score		12 months
Secondary	Mortality		12 months
Secondary	Procedural complications		Index-procedure
Secondary	Reintervention	Any peripheral venous intervention after the index-procedure to restore patency in the treated segment or outside the treated segment	12 months