Deep Venous Disease of the Lower LimbsEVeRNCT06906250
European Venous Registry
An observational study of Deep Venous Disease of the Lower Limbs, run by IRCCS San Raffaele at 10 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Disease of the Lower Limbs
- How many people
- 100 participants
- Where
- 10 sitesin 9 countries
- Study dates
- 5 Jul 2025to 30 Sep 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 9 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
North Bristol NHS Trust
Bristol, United Kingdom
Baris Ozdemir, nhi@esvs.org, nhi@esvs.org
Baris Ozdemir, Mr.
- Recruiting
St Thomas' Hospital
London, United Kingdom
Steve Black, nhi@esvs.org, nhi@esvs.org
Steve Black, Prof., MD
France1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery
Marseille, France
Olivier Hartung, nhi@esvs.org, nhi@esvs.org
Germany1 site, 1 recruiting
- Recruiting
European Venous Center
Aachen, Germany
Houman Jalaie, nhi@esvs.org, nhi@esvs.org
Houman Jalaie, Prof., MD
Greece1 site, 1 recruiting
- Recruiting
Clinic of Vascular and Endovascular Surgery at Athens Medical Group
Athens, Greece
Makis Avgerinos, nhi@esvs.org, nhi@esvs.org
Makis Avgerinos, Prof., MD
Ireland1 site, 1 recruiting
- Recruiting
Interventional Radiology, Galway University Hospitals
Galway, Ireland
Gerry O'Sullivan, nhi@esvs.org, nhi@esvs.org
Gerry O'Sullivan, Prof., MD
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Hospital
Milan, Italy, 20132
Domenico Baccellieri, 0226437377, domenico.baccellieri@hsr.it
Domenico Baccellieri, Prof., MD
Netherlands1 site, 1 recruiting
- Recruiting
Department of Vascular and Endovascular Surgery, Erasmus Medical Centre
Rotterdam, Netherlands
Marie Josee Van Rijn, nhi@esvs.org, nhi@esvs.org
Marie Josee Van Rijn, Dr.
Spain1 site, 1 recruiting
- Recruiting
Vascular and Endovascular Department, Viamed Hospitals
Madrid, Spain
Marta Ramirez Ortega, nhi@esvs.org, nhi@esvs.org
Marta Ramirez Ortega, Dr.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery, Acibadem University School of Medicine,
Istanbul, Turkey
Mert Dumantepe, nhi@esvs.org, nhi@esvs.org
Mert Dumantepe, Prof., MD
About this study
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.
- Conditions
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients suffering from deep venous disease of the lower limbs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start5 Jul 2025
- Primary completion30 Sep 2034 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous Disease of the Lower LimbsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baccellieri Domenico, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906250
- Sponsor's protocol ID
- EVeR- European Venous Registry
- Acronym
- EVeR
- Status last verified
- Sep 2025
- First submitted
- 19 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Venous Registry
- ClinicalTrials.gov ID
- NCT06906250
- Acronym / sponsor ID
- EVeR / EVeR- European Venous Registry
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 30 Sep 2034 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients suffering from deep venous disease of the lower limbs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinic of Vascular and Endovascular Surgery at Athens Medical Group
Athens, Greece
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Disease of the Lower Limbs, run by IRCCS San Raffaele at 10 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, France, Germany, Greece, Ireland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Severity Scores (time frame: end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.