Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-24 @ 9:09 PM
Study NCT ID:
NCT06906250
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Venous Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2034-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Severity Scores', 'timeFrame': 'end of the procedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Venous Insufficiency Epidemiological and Economic Study/Quality of Life (VEINES-QOL)', 'timeFrame': '10 years', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute or chronic lower limb deep venous disease', 'iliac and/or common femoral veins', 'inferior vena cava'], 'conditions': ['Deep Venous Disease of the Lower Limbs']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://esvs.org/ever-venous-registry/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Consent to enter registry.\n\nExclusion Criteria:\n\n* Unable to consent to enter into registry.\n* Isolated upper limb DVT.\n* Central venous thrombosis (e.g. superior vena cava obstruction).\n* Isolated deep vein thrombosis below the common femoral vein.\n* Isolated superficial venous thrombosis.\n* Isolated superficial venous thrombophlebitis.\n* Isolated varicose veins.\n* Aged \\<18 years.'}, 'identificationModule': {'nctId': 'NCT06906250', 'acronym': 'EVeR', 'briefTitle': 'European Venous Registry', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'European Venous Registry', 'orgStudyIdInfo': {'id': 'EVeR- European Venous Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'all patients suffering from deep venous disease of the lower limbs'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Hartung', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}], 'facility': 'Department of Vascular Surgery', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Aachen', 'state': 'Germany', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Houman Jalaie', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Houman Jalaie, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Venous Center', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Athens', 'state': 'Greece', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Makis Avgerinos', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Makis Avgerinos, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic of Vascular and Endovascular Surgery at Athens Medical Group', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Galway', 'state': 'Ireland', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': "Gerry O'Sullivan", 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': "Gerry O'Sullivan, Prof., MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Interventional Radiology, Galway University Hospitals', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Baccellieri', 'role': 'CONTACT', 'email': 'domenico.baccellieri@hsr.it', 'phone': '0226437377'}, {'name': 'Domenico Baccellieri, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rotterdam', 'state': 'Netherlands', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marie Josee Van Rijn', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Marie Josee Van Rijn, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Vascular and Endovascular Surgery, Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Madrid', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta Ramirez Ortega', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Marta Ramirez Ortega, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vascular and Endovascular Department, Viamed Hospitals', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Istanbul', 'state': 'Turkey', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mert Dumantepe', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Mert Dumantepe, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Cardiovascular Surgery, Acibadem University School of Medicine,', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Bristol', 'state': 'United Kingdom', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Baris Ozdemir', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Baris Ozdemir, Mr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'London', 'state': 'United Kingdom', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Steve Black', 'role': 'CONTACT', 'email': 'nhi@esvs.org', 'phone': 'nhi@esvs.org'}, {'name': 'Steve Black, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof., M.D', 'investigatorFullName': 'Baccellieri Domenico', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}