European Venous Registry

Not yet recruiting

• Conditions: Deep Venous Disease of the Lower Limbs

• Registration Number: NCT06906250
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-25
• Status Verified: 2025-04
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-01
• Primary Completion: 2034-09-30
• Study Completion: 2034-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Severity Scores	end of the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)	10 years	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.

Trial Locations

Locations (10)

Department of Cardiovascular Surgery, Acibadem University School of Medicine,; 🇹🇷 Istanbul, Turkey

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

St Thomas' Hospital; 🇬🇧 London, United Kingdom

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy

Vascular and Endovascular Department, Viamed Hospitals; 🇪🇸 Madrid, Spain

Department of Vascular Surgery; 🇫🇷 Marseille, France

European Venous Center; 🇩🇪 Aachen-Maastricht, Germany

Clinic of Vascular and Endovascular Surgery at Athens Medical Group; 🇬🇷 Athens, Greece

Interventional Radiology, Galway University Hospitals; 🇮🇪 Galway, Ireland

Department of Vascular and Endovascular Surgery, Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands