Clinical trial NCT04683458: Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices
Official title: GermanVasc/MDEpiNet Paclitaxel Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paclitaxel Adverse Reaction
Outcome, Fatal
Keywords: Paclitaxel
Health Insurance Claims
Real-World Data
Quality Improvement
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: GermanVasc
name: BARMER
name: MDEpiNet Verband Deutschland e.V.
First posted: 2020-12-24
Enrollment: 14000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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, 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Hybrid surgery
* Previous major amputation
* Previous cancer diagnosis
* Previous paclitaxel-exposure
* Previous percutaneous coronary intervention
* Previous revascularisation of the arteries in the lower limbs

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
Study officials:
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