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

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Paclitaxel Adverse Reaction; Outcome, Fatal

Treatments: Device: Drug-coated device

Study type: Observational

Funder types: Other

Identifiers

NCT04683458

20GermanVasc

Details and patient eligibility

About

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.

Enrollment: 14,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

14,000 participants in 2 patient groups

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).

Treatment:

Device: Drug-coated device

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).