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Clinical Trials/NCT06906250
NCT06906250RecruitingNot Applicable

European Venous Registry

IRCCS San Raffaele10 sites in 9 countries100 target enrollmentStarted: July 5, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
10
Primary Endpoint
Clinical Severity Scores
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)(10 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Baccellieri Domenico

Prof., M.D

IRCCS San Raffaele

Study Sites (10)

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