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RecruitingNCT06906250EVeRUpdated Sep 8, 2025

European Venous Registry

An observational study in Deep Venous Disease of the Lower Limbs, sponsored by IRCCS San Raffaele. Recruiting at 10 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Deep Venous Disease of the Lower Limbs

Keywords

  • acute or chronic lower limb deep venous disease
  • iliac and/or common femoral veins
  • inferior vena cava
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In context

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • all patients suffering from deep venous disease of the lower limbs
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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

10 of 10 sites recruiting
  • Department of Vascular Surgery
    Marseille, France, France
    Recruiting
  • European Venous Center
    Aachen, Germany, Germany
    • Houman Jalaie · Contact · nhi@esvs.org · nhi@esvs.org
    • Houman Jalaie, Prof., MD · Principal investigator
    Recruiting
  • Clinic of Vascular and Endovascular Surgery at Athens Medical Group
    Athens, Greece, Greece
    • Makis Avgerinos · Contact · nhi@esvs.org · nhi@esvs.org
    • Makis Avgerinos, Prof., MD · Principal investigator
    Recruiting
  • Interventional Radiology, Galway University Hospitals
    Galway, Ireland, Ireland
    • Gerry O'Sullivan · Contact · nhi@esvs.org · nhi@esvs.org
    • Gerry O'Sullivan, Prof., MD · Principal investigator
    Recruiting
  • IRCCS San Raffaele Hospital
    Milan, Italy 20132, Italy
    Recruiting
  • Department of Vascular and Endovascular Surgery, Erasmus Medical Centre
    Rotterdam, Netherlands, Netherlands
    • Marie Josee Van Rijn · Contact · nhi@esvs.org · nhi@esvs.org
    • Marie Josee Van Rijn, Dr. · Principal investigator
    Recruiting
  • Vascular and Endovascular Department, Viamed Hospitals
    Madrid, Spain, Spain
    • Marta Ramirez Ortega · Contact · nhi@esvs.org · nhi@esvs.org
    • Marta Ramirez Ortega, Dr. · Principal investigator
    Recruiting
  • Department of Cardiovascular Surgery, Acibadem University School of Medicine,
    Istanbul, Turkey, Turkey (Türkiye)
    • Mert Dumantepe · Contact · nhi@esvs.org · nhi@esvs.org
    • Mert Dumantepe, Prof., MD · Principal investigator
    Recruiting
  • North Bristol NHS Trust
    Bristol, United Kingdom, United Kingdom
    • Baris Ozdemir · Contact · nhi@esvs.org · nhi@esvs.org
    • Baris Ozdemir, Mr. · Principal investigator
    Recruiting
  • St Thomas' Hospital
    London, United Kingdom, United Kingdom
    • Steve Black · Contact · nhi@esvs.org · nhi@esvs.org
    • Steve Black, Prof., MD · Principal investigator
    Recruiting
08

References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06906250
Lead sponsor
IRCCS San Raffaele
Responsible party
Baccellieri Domenico (Prof., M.D, IRCCS San Raffaele) — Principal investigator
First posted
Apr 2, 2025
Start date
Jul 5, 2025
Primary completion
Sep 30, 2034 (estimated)
Completion
Sep 30, 2034 (estimated)
Last update
Sep 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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