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

• Conditions: Outcome, Fatal; Paclitaxel Adverse Reaction
• Interventions: Device: Drug-coated device

• Registration Number: NCT04683458
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Status Verified: 2021-01
• Study Start: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paclitaxel-coated devices	Drug-coated device	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).

Primary Outcome Measures

Name	Time	Method
Target limb revascularization after 5-years	5-years
Composite of all-cause mortality and major amputation of the lower extremities after 5-years	5-years
Composite of all-cause mortality, myocardial infarction, and stroke after 5-years	5-years
All-cause mortality after 5-years	5-years

Secondary Outcome Measures

Name	Time	Method
Major amputation of the target limb after 5-years	5-years
Minor amputation of the target limb after 5-years	5-years
Incident cancer after 5-years	5-years
Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs	1-year