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| Name | Class |
|---|---|
| GermanVasc | OTHER |
| BARMER | OTHER |
| MDEpiNet Verband Deutschland e.V. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-coated devices | 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). |
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| Controlls | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated device | Device | The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients above 39 years who underwent first (index) endovascular revascularisation for symptomatic peripheral arterial occlusive disease or diabetic foot syndrome with chronic limb-threatening ischaemia in Germany between 2013 and 2017.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian-Alexander Behrendt, PD Dr. | Contact | +4940741018087 | ch.behrendt@uke.de |
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| Label | URL |
|---|---|
| Publication List of the Principal Investigator | View source |
| Website of the German chapter of the Medical Device Epidemiology Network | View source |
| Website of the US Center of the Medical Device Epidemiology Network |
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| 5-years |
| Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs | 1-year |
| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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