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

NCT04683458 | Unknown FDA Device

• 1 other identifier: 20GermanVasc
• Study Type: observational
• Target: 14,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Paclitaxel Adverse Reaction; Outcome, Fatal

Keywords

Paclitaxel; Health Insurance Claims; Real-World Data; Quality Improvement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

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).

Device: Drug-coated device

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).

Interventions

Drug-coated device DEVICE

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

Also known as: Drug-coated balloon, Drug-eluting stent, Paclitaxel-coated device, Paclitaxel-coated balloon, Paclitaxel-eluting stent, DES, DCB

Paclitaxel-coated devices

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Fontaine stage II-IV
• Diabetic foot syndrome with chronic limb-threatening ischaemia
• Endovascular revascularisation procedure in the lower limbs
• Treatment between 2013 and 2017

You may not qualify if:

• Hybrid surgery
• Previous major amputation
• Previous cancer diagnosis
• Previous paclitaxel-exposure
• Previous percutaneous coronary intervention
• Previous revascularisation of the arteries in the lower limbs

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• GermanVasc: collaborator
• BARMER: collaborator
• MDEpiNet Verband Deutschland e.V.: collaborator

Related Links

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

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Christian-Alexander Behrendt, PD Dr.

CONTACT

+4940741018087; ch.behrendt@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2021
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01