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

GermanVasc/MDEpiNet Paclitaxel Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Outcome, Fatal; Paclitaxel Adverse Reaction
• Intervention / Treatment: Device: Drug-coated device

• Study Type: Observational
• Enrollment (Anticipated): 14000

Contacts and Locations

• Study Contact: Name: Christian-Alexander Behrendt, PD Dr.; Phone Number: +4940741018087; Email: ch.behrendt@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel; Other Names: Paclitaxel-eluting stent; DES; Drug-eluting stent; Drug-coated balloon; Paclitaxel-coated device; Paclitaxel-coated balloon; DCB
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: BARMER; GermanVasc; MDEpiNet Verband Deutschland e.V.

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Paclitaxel; Quality Improvement; Real-World Data; Health Insurance Claims
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 20GermanVasc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes