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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04683458
Other study ID # 20GermanVasc
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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