Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression

Optimed Medizinische Instrumente GmbH7 sites in 4 countries60 target enrollmentDecember 2016

ConditionsPost-thrombotic Syndrome Iliac Vein Compression Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post-thrombotic Syndrome
Sponsor: Optimed Medizinische Instrumente GmbH
Enrollment: 60
Locations: 7
Primary Endpoint: Primary Patency Rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective:

To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.

Secondary objective:

To assess long-term safety of venous stenting

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

December 17, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Optimed Medizinische Instrumente GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adults aged ≥18 years
•Post-thrombotic syndrome (Villalta score \>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
•Evidence of venous stenosis in common iliac vein \>50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
•Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
•If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses \>50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins

Exclusion Criteria

•Pregnancy, breast-feeding or birth-giving during the last 30 days
•Life expectancy \<6 months
•Iliofemoral DVT less than 3 months ago
•Permanently immobile patient (wheelchair user or bed-ridden patient)
•Allergy to Nitinol
•Patient's target vessel(s) has/have been stented before
•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 or official order