Paclitaxel Adverse ReactionPacliVascNCT04683458
Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices
An observational study of Paclitaxel Adverse Reaction and Outcome, Fatal, run by Universitätsklinikum Hamburg-Eppendorf.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Paclitaxel Adverse Reaction, Outcome, Fatal
- What is being tested?
- Drug-coated device
- Type of treatment
- Medical device
- How many people
- 14,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Fontaine stage II-IV
- Diabetic foot syndrome with chronic limb-threatening ischaemia
- Endovascular revascularisation procedure in the lower limbs
- Treatment between 2013 and 2017
Who cannot join
- Hybrid surgery
- Previous major amputation
- Previous cancer diagnosis
- Previous paclitaxel-exposure
- Previous percutaneous coronary intervention
- Previous revascularisation of the arteries in the lower limbs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Paclitaxel Adverse Reaction, Outcome, Fatal
- Being tested
- Drug-coated device
- Keywords
- Paclitaxel, Health Insurance Claims, Real-World Data, Quality Improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated deviceDevice
Also called Drug-coated balloon, Drug-eluting stent, Paclitaxel-coated device, Paclitaxel-coated balloon
The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality after 5-years
Measured: 5-years
Composite of all-cause mortality, myocardial infarction, and stroke after 5-years
Measured: 5-years
Composite of all-cause mortality and major amputation of the lower extremities after 5-years
Measured: 5-years
Target limb revascularization after 5-years
Measured: 5-years
Secondary outcomes (4)
Incident cancer after 5-years
Measured: 5-years
Minor amputation of the target limb after 5-years
Measured: 5-years
Major amputation of the target limb after 5-years
Measured: 5-years
Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paclitaxel Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- GermanVasc, BARMER, MDEpiNet Verband Deutschland e.V.
- Responsible party
- Principal investigator, Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683458
- Sponsor's protocol ID
- 20GermanVasc
- Acronym
- PacliVasc
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GermanVasc/MDEpiNet Paclitaxel Study
- ClinicalTrials.gov ID
- NCT04683458
- Acronym / sponsor ID
- PacliVasc / 20GermanVasc
- Conditions
- Paclitaxel Adverse Reaction, Outcome, Fatal
- Keywords
- Paclitaxel, Health Insurance Claims, Real-World Data, Quality Improvement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- GermanVasc, BARMER, MDEpiNet Verband Deutschland e.V.
- Study start
- Jan 2021 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated devices | – | Device: Drug-coated devicePatients 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). |
| 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Fontaine stage II-IV
- Diabetic foot syndrome with chronic limb-threatening ischaemia
- Endovascular revascularisation procedure in the lower limbs
- Treatment between 2013 and 2017
Key exclusion criteria (6 listed)
- Hybrid surgery
- Previous major amputation
- Previous cancer diagnosis
- Previous paclitaxel-exposure
- Previous percutaneous coronary intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-coated deviceAlso: Drug-coated balloon, Drug-eluting stent, Paclitaxel-coated device, Paclitaxel-coated balloonThe endovascular (intraluminal) application of a medical-device that was coated with paclitaxel | Device | Paclitaxel-coated devices |
Primary outcome
All-cause mortality after 5-years
Time frame: 5-years
Composite of all-cause mortality, myocardial infarction, and stroke after 5-years
Time frame: 5-years
Composite of all-cause mortality and major amputation of the lower extremities after 5-years
Time frame: 5-years
Target limb revascularization after 5-years
Time frame: 5-years
4 secondary outcomes
Incident cancer after 5-years
Time frame: 5-years
Minor amputation of the target limb after 5-years
Time frame: 5-years
Major amputation of the target limb after 5-years
Time frame: 5-years
Rate of optimal pharmacological treatment with antithrombotics, antihypertensives, and lipid-lowering drugs
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Publication List of the Principal InvestigatorLink provided by the sponsor.
- Website of the German chapter of the Medical Device Epidemiology NetworkLink provided by the sponsor.
- Website of the US Center of the Medical Device Epidemiology NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Paclitaxel Adverse Reaction and Outcome, Fatal, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian-Alexander Behrendt, PD Dr. (+4940741018087, ch.behrendt@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality after 5-years (time frame: 5-years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.