NCT04683458

Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices

GermanVasc/MDEpiNet Paclitaxel Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 14,000 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paclitaxel Adverse Reaction
• Outcome, Fatal

Interventions

Type	Name	Description
DEVICE	Drug-coated device	The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-12-24
• Last updated: 2021-01-15

Regulatory

• FDA-regulated device study