Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02942394
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D062108', 'term': 'May-Thurner Syndrome'}], 'ancestors': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency Rate', 'timeFrame': 'After 3 months up to a follow-up of 2 years.'}], 'secondaryOutcomes': [{'measure': 'Primary Assisted Patency Rate', 'timeFrame': 'After 3 months up to a follow-up of 2 years.'}, {'measure': 'Secondary Patency Rate', 'timeFrame': 'After 3 months up to a follow-up of 2 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-thrombotic Syndrome', 'Iliac Vein Compression Syndrome']}, 'descriptionModule': {'briefSummary': "Primary objective:\n\nTo assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.\n\nSecondary objective:\n\nTo assess long-term safety of venous stenting"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with post-thrombotic syndrome and concomitant common iliac vein compression.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female adults aged ≥18 years\n2. Post-thrombotic syndrome (Villalta score \\>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis\n3. Evidence of venous stenosis in common iliac vein \\>50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)\n4. Use of sinus-Obliquus stent for unilateral common iliac vein stenosis\n5. If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses \\>50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins\n\nExclusion Criteria:\n\n1. Pregnancy, breast-feeding or birth-giving during the last 30 days\n2. Life expectancy \\<6 months\n3. Iliofemoral DVT less than 3 months ago\n4. Permanently immobile patient (wheelchair user or bed-ridden patient)\n5. Allergy to Nitinol\n6. Patient's target vessel(s) has/have been stented before\n7. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study\n8. Patients in custody by juridical or official order"}, 'identificationModule': {'nctId': 'NCT02942394', 'briefTitle': 'Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optimed Medizinische Instrumente GmbH'}, 'officialTitle': 'Non-interventional, Multicenter, Multinational Venous Stent Study for the Treatment of the Post-thrombotic Syndrome With Common Iliac Vein Compression', 'orgStudyIdInfo': {'id': 'SONIS15473'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sinus-Obliquus Stent System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '59759', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Karolinen Hospital Arnsberg', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Medizinische Universitätsklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '66424', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universität des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '6229', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital MUMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'INSELSPITAL, Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Nils Kucher, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director Clinic for Angiology Universitätsspital Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimed Medizinische Instrumente GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}