Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-25 @ 12:22 PM
Study NCT ID:
NCT05662761
Status:
RECRUITING
Last Update Posted:
2022-12-22
First Post:
2022-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain -free walking distance', 'timeFrame': '2022-2025', 'description': 'pain-free walking distance after venous recanalization and stent implantation'}], 'secondaryOutcomes': [{'measure': 'Stent openness rate', 'timeFrame': '2022-2025', 'description': 'Stent openness rate'}, {'measure': '2', 'timeFrame': '2022-2025', 'description': 'Quality of life of the patients after venous recanalization and stent-lmpl.antption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication', 'detailedDescription': 'The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with obstruction in the common femoral vein, external iliac vein, common iliac vein, or inferior vena cava', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior\n2. Age: 18-80 years old\n3. Signed informed consent form\n4. Persons who are legally competent and mentally capable, to follow the instructions of the staff\n\nExclusion Criteria:\n\n1. Patients under 18 years of age.\n2. Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.\n3. Persons acting by administrative or judicial order are housed in a facility\n4. Patients who abuse drugs\n5. Peripheral arterial disease stage IIb, III and IV -'}, 'identificationModule': {'nctId': 'NCT05662761', 'acronym': 'TIRED', 'briefTitle': 'Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication', 'orgStudyIdInfo': {'id': 'Universitätsklinikum Aachen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'symptomatic chronic obstruction', 'description': 'patients with symptomatic chronic obstruction of the femoroiliac and caval vein segments (VFC, VIE, VIC, VCI) treated with stent angioplasty.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Universitätsklinikum Aachen', 'role': 'CONTACT', 'email': 'gheuer@ukaachen.de', 'phone': '02418035881'}, {'name': 'Mohammad E Barbati, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Mohammad E Barbati, MD', 'role': 'CONTACT', 'email': 'mbarbati@ukaachen.de', 'phone': '+492418035292'}, {'name': 'Gaby Heuer, SN', 'role': 'CONTACT', 'email': 'gheuer@ukaachen.de', 'phone': '+492418035881'}], 'overallOfficials': [{'name': 'Houman Jalaie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Aachen Klinik für Gefäßchirurgie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of the Department of Vascular & Endovascular Surgery of the University Hospital of AachenPD Dr. med Houman Jalaie', 'investigatorFullName': 'Houman Jalaie', 'investigatorAffiliation': 'RWTH Aachen University'}}}}