Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 3:09 PM
Study NCT ID:
NCT03116750
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success (removal of occlusion and restoration of blood flow)', 'timeFrame': 'day of treatment', 'description': 'Primary patency'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'through study completion of 3 years', 'description': 'failure of usability'}, {'measure': 'Adverse device effects', 'timeFrame': 'through study completion of 3 years', 'description': 'device related safety variables'}, {'measure': 'Technical success rate', 'timeFrame': 'intraoperative', 'description': 'removal of occlusion'}, {'measure': 'Swelling of limb', 'timeFrame': 'through study completion of 3 years', 'description': 'Circumference of the limb'}, {'measure': 'Pain improvement', 'timeFrame': 'through study completion of 3 years', 'description': 'pain disability index'}, {'measure': 'additional Treatment , acute', 'timeFrame': 'before 72 hours after treatment', 'description': 'index treatment at index site'}, {'measure': 'additional Treatment, Long term', 'timeFrame': 'later than 72 hours after treatment', 'description': 'index treatment at index site'}, {'measure': 'Hospital Stay', 'timeFrame': '4-5 days after treatment', 'description': 'Duration of hospital stay'}, {'measure': 'Time to return back to ward', 'timeFrame': 'day of treatment', 'description': 'Treatment time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical thrombectomy'], 'conditions': ['Deep Vein Thrombosis', 'Bypass Complication', 'Dialysis Shunt', 'Stent Occlusion']}, 'descriptionModule': {'briefSummary': 'The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.\n\nCAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.\n\nASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Main study population: patients with DVT of the pelvis, legs and vena cava inferior.\n\nAdditional patients with dialysis shunts and / or other bypasses, vena subclavia, vena brachiocephalica, vena cava superior, vena splenica and vena mesenterica superior/inferior will be included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute thrombotic or thromboembolic occlusion (onset of pain \\< 14 days)\n2. Age \\> 18 years\n3. Written informed consent form\n\nExclusion Criteria:\n\n1. Patient not suitable for thrombectomy\n2. Fracture area of broken stents\n3. Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure\n4. Persistent vasospasm\n5. Severe coagulatory disorders\n6. Patients with thrombophilia\n7. Aneurysmatically altered vessel segments on target zone or on passage of catheter\n8. Known or suspected infection, especially of the puncture site or the vessel segment being treated\n9. Known, unhealed pre-existing mechanical damage to the vessel wall, especially caused by surgical procedures or interventional complications\n10. Immature or not fully healed dialysis accesses or bypass grafts\n11. Female subjects of childbearing capacity who are not willing to employ contraceptive measures\n12. Pregnant or breast feeding subjects\n13. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study\n14. Subjects who are lawfully kept in an institution\n15. Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures\n16. Current participation in any other clinical study (medicinal, medical device) or within the last 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT03116750', 'acronym': 'P-MAX', 'briefTitle': 'Post-Market Clinical Follow-up Study with ASPIREX®S to Assess the Safety and Effectiveness in the Treatment of DVT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Straub Medical AG'}, 'officialTitle': 'Post-Market Clinical Follow-up Study with the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups', 'orgStudyIdInfo': {'id': '15k013'}}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universität Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '21079', 'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'country': 'France', 'facility': 'CHU - Hôpital François-Mitterrand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '59755', 'city': 'Arnsberg', 'country': 'Germany', 'facility': 'Klinikum Arnsberg, Klinik für Angiologie', 'geoPoint': {'lat': 51.38333, 'lon': 8.08333}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'H91YR71', 'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Giovanni Addolorata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Straub Medical AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}