Outcome, Fatal Clinical Trial
— PacliVascOfficial title:
GermanVasc/MDEpiNet Paclitaxel Study
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.
Status | Not yet recruiting |
Enrollment | 14000 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | BARMER, GermanVasc, MDEpiNet Verband Deutschland e.V. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality after 5-years | 5-years | ||
Primary | Composite of all-cause mortality, myocardial infarction, and stroke after 5-years | 5-years | ||
Primary | Composite of all-cause mortality and major amputation of the lower extremities after 5-years | 5-years | ||
Primary | Target limb revascularization after 5-years | 5-years | ||
Secondary | Incident cancer after 5-years | 5-years | ||
Secondary | Minor amputation of the target limb after 5-years | 5-years | ||
Secondary | Major amputation of the target limb after 5-years | 5-years | ||
Secondary | Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs | 1-year |
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