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

Study Overview
=================
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.

Official Title
-----------------
GermanVasc/MDEpiNet Paclitaxel Study

Conditions
-----------------
Paclitaxel Adverse Reaction, Outcome, Fatal

Intervention / Treatment
-----------------
* Device: Drug-coated device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paclitaxel-coated devices<br>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). | Device: Drug-coated device<br>* The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel<br>* Other names: DCB;|
| Controlls<br>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). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality after 5-years |  | 5-years | 
| Composite of all-cause mortality, myocardial infarction, and stroke after 5-years |  | 5-years | 
| Composite of all-cause mortality and major amputation of the lower extremities after 5-years |  | 5-years | 
| Target limb revascularization after 5-years |  | 5-years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paclitaxel, Health Insurance Claims, Real-World Data, Quality Improvement