European Venous Registry (EVeR)

September 1, 2025 updated by: Baccellieri Domenico, IRCCS San Raffaele
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • France
      • Marseille, France, France
        • Recruiting
        • Department of Vascular Surgery
        • Contact:
          • Olivier Hartung
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
  • Germany
    • Germany
      • Aachen, Germany, Germany
        • Recruiting
        • European Venous Center
        • Contact:
          • Houman Jalaie
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Houman Jalaie, Prof., MD
  • Greece
    • Greece
      • Athens, Greece, Greece
        • Recruiting
        • Clinic of Vascular and Endovascular Surgery at Athens Medical Group
        • Contact:
          • Makis Avgerinos
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Makis Avgerinos, Prof., MD
  • Ireland
    • Ireland
      • Galway, Ireland, Ireland
        • Recruiting
        • Interventional Radiology, Galway University Hospitals
        • Contact:
          • Gerry O'Sullivan
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Gerry O'Sullivan, Prof., MD
  • Italy
    • Italy
      • Milan, Italy, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Hospital
        • Contact:
        • Principal Investigator:
          • Domenico Baccellieri, Prof., MD
  • Netherlands
    • Netherlands
      • Rotterdam, Netherlands, Netherlands
        • Recruiting
        • Department of Vascular and Endovascular Surgery, Erasmus Medical Centre
        • Contact:
          • Marie Josee Van Rijn
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Marie Josee Van Rijn, Dr.
  • Spain
    • Spain
      • Madrid, Spain, Spain
        • Recruiting
        • Vascular and Endovascular Department, Viamed Hospitals
        • Contact:
          • Marta Ramirez Ortega
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Marta Ramirez Ortega, Dr.
  • Turkey (Türkiye)
    • Turkey
      • Istanbul, Turkey, Turkey (Türkiye)
        • Recruiting
        • Department of Cardiovascular Surgery, Acibadem University School of Medicine,
        • Contact:
          • Mert Dumantepe
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Mert Dumantepe, Prof., MD
  • United Kingdom
    • United Kingdom
      • Bristol, United Kingdom, United Kingdom
        • Recruiting
        • North Bristol NHS Trust
        • Contact:
          • Baris Ozdemir
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Baris Ozdemir, Mr.
      • London, United Kingdom, United Kingdom
        • Recruiting
        • St Thomas' Hospital
        • Contact:
          • Steve Black
          • Phone Number: nhi@esvs.org
          • Email: nhi@esvs.org
        • Principal Investigator:
          • Steve Black, Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population sampled for data collection includes all patients suffering from deep venous disease of the lower limbs who are treated in the centres joining the registry. These include patients receiving surgery as well as those not receiving surgery. Only prospective patients will be allowed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
all patients suffering from deep venous disease of the lower limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Severity Scores
Time Frame: 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.
end of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Domenico Baccellieri, Prof., MD, IRCCS San Raffaele Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2025

Primary Completion (Estimated)

September 30, 2034

Study Completion (Estimated)

September 30, 2034

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EVeR- European Venous Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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