Status:
UNKNOWN
Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
GermanVasc
BARMER
Conditions:
Paclitaxel Adverse Reaction
Outcome, Fatal
Eligibility:
All Genders
40+ years
Brief Summary
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, in...
Eligibility Criteria
Inclusion
- Fontaine stage II-IV
- Diabetic foot syndrome with chronic limb-threatening ischaemia
- Endovascular revascularisation procedure in the lower limbs
- Treatment between 2013 and 2017
Exclusion
- Hybrid surgery
- Previous major amputation
- Previous cancer diagnosis
- Previous paclitaxel-exposure
- Previous percutaneous coronary intervention
- Previous revascularisation of the arteries in the lower limbs
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
14000 Patients enrolled
Trial Details
Trial ID
NCT04683458
Start Date
January 1 2021
End Date
February 1 2021
Last Update
January 15 2021
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