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

Outcome, Fatal Clinical Trial

— PacliVasc  

Official title:

GermanVasc/MDEpiNet Paclitaxel Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04683458
• Other study ID #: 20GermanVasc
• Status: Not yet recruiting
• Start date: January 2021
• Est. completion date: February 2021

Study information

• Verified date: January 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Christian-Alexander Behrendt, PD Dr.
• Phone: +4940741018087
• Email: ch.behrendt[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14000
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Outcome, Fatal
• Paclitaxel Adverse Reaction

Intervention

Device:
• Drug-coated device
The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	BARMER, GermanVasc, MDEpiNet Verband Deutschland e.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality after 5-years		5-years
Primary	Composite of all-cause mortality, myocardial infarction, and stroke after 5-years		5-years
Primary	Composite of all-cause mortality and major amputation of the lower extremities after 5-years		5-years
Primary	Target limb revascularization after 5-years		5-years
Secondary	Incident cancer after 5-years		5-years
Secondary	Minor amputation of the target limb after 5-years		5-years
Secondary	Major amputation of the target limb after 5-years		5-years
Secondary	Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs		1-year

External Links

•   Publication List of the Principal Investigator
•   Website of the German chapter of the Medical Device Epidemiology Network
•   Website of the responsible research group
•   Website of the US Center of the Medical Device Epidemiology Network