Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study

NCT02942394 | Completed

• 1 other identifier: SONIS15473
• Study Type: observational
• Target: 60
• Locations: 4 countries
• Sites: 7

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

Conditions

Post-thrombotic Syndrome; Iliac Vein Compression Syndrome

Outcome Measures

Primary Outcomes (1)

• Primary Patency Rate

  After 3 months up to a follow-up of 2 years.

Secondary Outcomes (2)

• Primary Assisted Patency Rate

  After 3 months up to a follow-up of 2 years.

• Secondary Patency Rate

  After 3 months up to a follow-up of 2 years.

Interventions

sinus-Obliquus Stent System DEVICE

Eligibility Criteria

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

Study Population

Patients with post-thrombotic syndrome and concomitant common iliac vein compression.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optimed Medizinische Instrumente GmbH: lead

Study Sites (7)

Allgemeines Krankenhaus der Stadt Wien

Vienna, 1090, Austria

Location

Karolinen Hospital Arnsberg

Arnsberg, 59759, Germany

Location

Medizinische Universitätsklinik Heidelberg

Heidelberg, 69120, Germany

Location

Universität des Saarlandes

Homburg, 66424, Germany

Location

Maastricht University Hospital MUMC+

Maastricht, 6229, Netherlands

Location

INSELSPITAL, Universitätsspital Bern

Bern, 3010, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Postthrombotic Syndrome; May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Vascular Malformations; Cardiovascular Abnormalities; Peripheral Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nils Kucher, Prof. Dr. med.

  Director Clinic for Angiology Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 24, 2016
• Study Start: December 1, 2016
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

DE (3); CH (2); AU (1); NL (1)