Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-02 @ 3:41 AM
Study NCT ID:
NCT04683458
Status:
UNKNOWN
Last Update Posted:
2021-01-15
First Post:
2020-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-12-19', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality after 5-years', 'timeFrame': '5-years'}, {'measure': 'Composite of all-cause mortality, myocardial infarction, and stroke after 5-years', 'timeFrame': '5-years'}, {'measure': 'Composite of all-cause mortality and major amputation of the lower extremities after 5-years', 'timeFrame': '5-years'}, {'measure': 'Target limb revascularization after 5-years', 'timeFrame': '5-years'}], 'secondaryOutcomes': [{'measure': 'Incident cancer after 5-years', 'timeFrame': '5-years'}, {'measure': 'Minor amputation of the target limb after 5-years', 'timeFrame': '5-years'}, {'measure': 'Major amputation of the target limb after 5-years', 'timeFrame': '5-years'}, {'measure': 'Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs', 'timeFrame': '1-year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Paclitaxel', 'Health Insurance Claims', 'Real-World Data', 'Quality Improvement'], 'conditions': ['Paclitaxel Adverse Reaction', 'Outcome, Fatal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://germanvasc.de', 'label': 'Website of the responsible research group'}, {'url': 'http://christianbehrendt.net', 'label': 'Publication List of the Principal Investigator'}, {'url': 'http://mdepinet.de', 'label': 'Website of the German chapter of the Medical Device Epidemiology Network'}, {'url': 'http://mdepinet.org', 'label': 'Website of the US Center of the Medical Device Epidemiology Network'}]}, 'descriptionModule': {'briefSummary': "The GermanVasc/MDEpiNet Paclitaxel Study, aims to use routinely collected data from health insurance claims and registries. The longitudinal data of Germany's second-largest insurance fund, BARMER, includes the outpatient and inpatient medical care provided to ≈9.4 million German citizens (13.2% of Germany's population) involving \\>21 million hospitalizations between January 1, 2008, and December 31, 2018. The BARMER cohort is similar to Western European countries and has been widely used for research projects. A regular random sample validation of internal and external validity is performed by the Medical Service of the Health Funds in Germany, and various peer-reviewed validation studies have been previously published. The GermanVasc clinical registry was implemented in 2018 as EU General Data Protection Regulation (GDPR) compliant registry platform to process routinely collected clinical data from more than 35 high-volume vascular centers in Germany. In an ongoing project of a large multispecialty and multidisciplinary research consortium (RABATT study, Principal Investigator: PD Dr. Christian-Alexander Behrendt), active surveillance and medical device evaluation methods were developed. The current study aims to determine the long-term safety and efficacy of paclitaxel-coated balloons and stents in peripheral arteries. It further aims to illuminate the underlying differences between the cohorts in randomized controlled trials (RCT) and real-world data that can possibly explain the diametrically opposed results in an ongoing international controversy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients above 39 years who underwent first (index) endovascular revascularisation for symptomatic peripheral arterial occlusive disease or diabetic foot syndrome with chronic limb-threatening ischaemia in Germany between 2013 and 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fontaine stage II-IV\n* Diabetic foot syndrome with chronic limb-threatening ischaemia\n* Endovascular revascularisation procedure in the lower limbs\n* Treatment between 2013 and 2017\n\nExclusion Criteria:\n\n* Hybrid surgery\n* Previous major amputation\n* Previous cancer diagnosis\n* Previous paclitaxel-exposure\n* Previous percutaneous coronary intervention\n* Previous revascularisation of the arteries in the lower limbs'}, 'identificationModule': {'nctId': 'NCT04683458', 'acronym': 'PacliVasc', 'briefTitle': 'Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'GermanVasc/MDEpiNet Paclitaxel Study', 'orgStudyIdInfo': {'id': '20GermanVasc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paclitaxel-coated devices', 'description': 'Patients with symptomatic peripheral arterial occlusive disease or diabetic foot syndrome with chronic limb-threatening ischaemia who underwent endovascular revascularisation of the peripheral arteries in the lower limbs with any drug-coated medical device (e.g., drug-eluting stent, drug-coated balloon).', 'interventionNames': ['Device: Drug-coated device']}, {'label': 'Controlls', 'description': 'Patients with symptomatic peripheral arterial occlusive disease or diabetic foot syndrome with chronic limb-threatening ischaemia who underwent endovascular revascularisation of the peripheral arteries in the lower limbs with any medical device except drug-coated techniques (e.g., drug-eluting stent, drug-coated balloon).'}], 'interventions': [{'name': 'Drug-coated device', 'type': 'DEVICE', 'otherNames': ['Drug-coated balloon', 'Drug-eluting stent', 'Paclitaxel-coated device', 'Paclitaxel-coated balloon', 'Paclitaxel-eluting stent', 'DES', 'DCB'], 'description': 'The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel', 'armGroupLabels': ['Paclitaxel-coated devices']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christian-Alexander Behrendt, PD Dr.', 'role': 'CONTACT', 'email': 'ch.behrendt@uke.de', 'phone': '+4940741018087'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'GermanVasc', 'class': 'OTHER'}, {'name': 'BARMER', 'class': 'OTHER'}, {'name': 'MDEpiNet Verband Deutschland e.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Behrendt', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}