European Venous Registry

IRCCS San Raffaele100 enrolled

Overview

The European Venous Registry (EVeR) is an international repository of data on the treatments and outcomes of people with deep venous disease. The registry is designed to evaluate the outcomes of venous interventions over a ten-year period, with the ultimate goal to inform clinical decision making through the delivery of scientific evidence.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Deep Venous Disease of the Lower Limbs

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with an imaging-confirmed new diagnosis of acute or chronic lower limb deep venous disease involving the iliac and/or common femoral veins, with or without extension to the inferior vena cava, or patients with an imaging-confirmed new diagnosis involving the IVC only. * Consent to enter registry. Exclusion Criteria: * Unable to consent to enter into registry. * Isolated upper limb DVT. * Central venous thrombosis (e.g. superior vena cava obstruction). * Isolated deep vein thrombosis below the common femoral vein. * Isolated superficial venous thrombosis. * Isolated superficial venous thrombophlebitis. * Isolated varicose veins. * Aged \<18 years.

Locations (10)

Department of Vascular Surgery

Marseille, France, France

RECRUITING

European Venous Center

Aachen, Germany, Germany

RECRUITING

Outcomes

Primary Outcomes

Clinical Severity Scores

Difference of Clinical efficacy will be evaluated using the Villalta score (range 0-33). The patient was diagnosed as having Post-thrombotic syndrome if the Villalta score was ≥5 or if a venous ulcer was present. A score of 5-9 signifies mild disease, 10-14 moderate disease, and ≥15 severe disease.

Time frame: end of the procedure

Secondary Outcomes

Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)

Improvement of quality of life will be evaluated using the Veines - qol score.The VEINES-QOL questionnaire consists of 26 items. Each question is standardised using the mean and standard deviation of the sample being coded to give a z-score, these are averaged, and the result transformed to T-scores (mean = 50; standard deviation = 10). High values indicate better outcomes.

Time frame: 10 years

Data from ClinicalTrials.gov

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