Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-05-29 @ 1:43 PM
Study NCT ID:
NCT03985150
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2019-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The superficial femoral artery will be collected from the amputated limb'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.', 'timeFrame': 'up to 3 years', 'description': 'Planar biaxial tension tests will be performed on the collected tissue. The results of these tests, in the form of stress-stretch curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.'}, {'measure': 'Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.', 'timeFrame': 'up to 3 years', 'description': 'Extension-inflation tests will be performed on the collected tissue. The results of these tests, in the form of axial force and diameter curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.'}, {'measure': 'Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.', 'timeFrame': 'up to 3 years', 'description': 'Indentation tests will be performed on the collected tissue. The results of these tests, in the form of reaction force versus indentation depth curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.'}], 'secondaryOutcomes': [{'measure': 'Microstructural composition of diseased superficial femoral arterial tissue from histological analyses', 'timeFrame': 'up to 3 years', 'description': 'Histological images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.'}, {'measure': 'Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses', 'timeFrame': 'up to 3 years', 'description': 'MicroCT images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The current treatment approaches for peripheral artery disease are largely unsatisfactory. Therefore, diseased tissue will be collected as well as patient-specific arterial geometries. The tissue will be tested microstructurally and mechanically to obtain data required to optimize treatment methods through in silico modeling.', 'detailedDescription': 'Peripheral artery disease (PAD) is a severe cause of morbidity in patients. Common treatment approaches are too often still unsatisfactory. Angioplasty is commonly followed by restenosis, caused by overloading of the arterial tissue. This study is aimed at improving this treatment approach through the in silico simulation of arterial remodeling after balloon expansion. Such simulations require the input of a patient-specific geometry and the mechanical properties of (diseased) arterial tissue.\n\nPatients scheduled for an above knee lower limb amputation due to critical ischemia will be recruited in this study. After the surgery, the femoralis superficialis will be collected, as well as the CT or MR angiogram obtained before the surgery. The arterial tissue will be mechanically tested to obtain material properties and the medical image will be used to determine the arterial geometry. A correlation study will be carried out to explore the possibility of including a predictive simulation of the restenosis outcome of balloon angioplasty in the clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from peripheral arterial disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from critical ischemia in the lower limb and undergoing above-knee amputation\n\nExclusion Criteria:\n\n* The presence of any feature that will prevent tissue collection after the amputation'}, 'identificationModule': {'nctId': 'NCT03985150', 'briefTitle': 'Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis', 'orgStudyIdInfo': {'id': 'S62776'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biomechanical analysis of femoralis superficialis atherosclerotic tissue', 'type': 'OTHER', 'description': 'Tissue collection during above-knee amputation; mechanical testing of tissue; microstructural testing of tissue'}, {'name': 'CT or MR angiogram', 'type': 'RADIATION', 'description': 'Obtaining in vivo geometry of diseased artery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}