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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04683458
• Collaborator: GermanVasc (Other), BARMER (Other), MDEpiNet Verband Deutschland e.V. (Other)
• Enrollment: 14,000
• Anticipated Duration (Months): 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Paclitaxel Adverse Reaction; Outcome, Fatal	Device: Drug-coated device

Study Design

• Study Type: Observational
• Anticipated Enrollment: 14000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: GermanVasc/MDEpiNet Paclitaxel Study
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	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: Drug-coated balloon Drug-eluting stent Paclitaxel-coated device Paclitaxel-coated balloon Paclitaxel-eluting stent DES 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).

Outcome Measures

Primary Outcome Measures

1. All-cause mortality after 5-years [5-years]

2. Composite of all-cause mortality, myocardial infarction, and stroke after 5-years [5-years]

3. Composite of all-cause mortality and major amputation of the lower extremities after 5-years [5-years]

4. Target limb revascularization after 5-years [5-years]

Secondary Outcome Measures

1. Incident cancer after 5-years [5-years]

2. Minor amputation of the target limb after 5-years [5-years]

3. Major amputation of the target limb after 5-years [5-years]

4. Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs [1-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Christian Behrendt, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT04683458
• Other Study ID Numbers: 20GermanVasc
• First Posted: Dec 24, 2020
• Last Update Posted: Jan 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Christian Behrendt, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf: Paclitaxel; Health Insurance Claims; Real-World Data; Quality Improvement
• Additional relevant MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Jan 15, 2021