Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017609

Trial Description

start of 1:1-Block title

Title

POPART Registry - What is the current treatment of aneurysms of the popliteal artery? - a registry for the indications of open surgical and endovascular therapy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

POPART

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.digg-dgg.de/fileadmin/websites/digg/Popart-what_is_popart_ENG_2015.pdf

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

POPART Registry is an international data collection of health information and clinical data of patients with a popliteal artery aneurysm. There will be a follow-up of at least five years. This data collection should help to improve treatment and knowledge about this disease and furthermore it should serve as a quality control tool.
For the future this data collection should help to find out the best option of treatment of popliteal artery aneurysms.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Popliteal artery aneurysms (PAA) are relatively rare. The VASCUNET Collaboration recently reported an average incidence of 9.6 PAA-treatments/million person years in 8 European countries. A therapy option for symptomatic PAA is indisputable and asymptomatic PAAs with a diameter of 2.0 cm or greater should also be treated (Evidence-Level B).

Evidence based concurrence as to whether a popliteal aneurysm should be treated by endovascasular (ER) or open reconstruction (OR) is lacking to date. Since PAAs are rare, the small case number makes it unfeasible to gather relevant data in a prospective, randomized study. The purpose of the register is to compile data from patients with popliteal artery aneurysms at many different centers. Over a time period determined by the total number of endovascular or open interventions performed, patients will be registered and then tracked for 5 years.

The register should answer the following questions:
1.) How often are PAAs treated by endovascular and open reconstruction in Europe (epidemiology)?
2.) Are the indications for OR and ER different (i.e. risk factors, age and particularly run off)?
3.) Which postoperative complications are encountered with OR and ER?
4.) What are the results 5 years after OR and ER? (primary and secondary patency, amputation free survival rate, intervention free survival, number of re-interventions, number and length of hospital stays)?
5.) What are the gender specific differences between OR and ER outcome, described but not quantified?
6.) Does aneurysm growth, despite intervention, occur during follow-up?
7.) What indications lead to intervention (aneurysm diameter, relationship of elective to emergency interventions)?
8.) Is vein or alloplastic material used in OR?
9.) Is posterior or medial access employed in OR (special attention to aneurysm growth)?
10.) How is anti-platelet-therapy and anticoagulation administered?

Data are entered into an online input mask on a SurveyMonkey platform. According to case status, automatic navigation to the appropriate input path is provided (for example: primary treatment or follow-up). Patients must be informed that they are listed in the register, they must be properly informed and they must give written consent. The goal of the data compilation is to incorporate many vascular surgery centers, to obtain the highest possible number of cases. Entering patient data is possible after receiving a password for access to the input mask.
Participating centers receive a structured monitoring programme. To ensure high data quality, all eCRFs are checked for plausibility by standardized query-documents. A Report of the registry will be published every year.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017609
  •   2019/09/09
  •   [---]*
  •   yes
  •   Approved
  •   218/14, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I72.4 -  Aneurysm and dissection of artery of lower extremity
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with a popliteal artery aneurysm who had an endovascular therapy. Perioperative data and follow-up data will be collected in eCRF.
  •   Patients with a popliteal artery aneurysm who received open surgery. Perioperative data and follow-up data will be collected in eCRF.
  •   Patients with a popliteal artery aneurysm who have an indication for treatment and stayed under surveillance for several reasons. Perioperative data and follow-up data will be collected in eCRF.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Death
Major amputation/limb-loss or occlusion of Reconstruction without consecutive revascularization are endpoints. Consequence is drop-out. These endpoints have to be reported, when they occur in eCRF.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Patency of the reconstruction. It is evaluated during follow-up visits by clinical examination, imaging (CT-scan, MR-scan, Doppler-imaging). Follow-up visits will follow the intervals of clinical examination, usually at least in 12 month intervals. No additional visits are planned (observational study).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Luxembourg
  •   Austria
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/06/25
  •   5000
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   150   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All patients (male and female) who are older than 18 years, who underwent treatment of a popliteal artery aneurysm.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

none

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsches Institut für Gefäßmedizinische Gesundheitsforschung (DIGG) gGmbH
    • Robert-Koch-Platz 9
    • 10115  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   030280990990
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Gefäß- und Endovascularchirurgie Universitätsklinikum Frankfurt am Main
    • Mr.  Dr. med.  Georg  Jung 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Gefäß- und Endovascularchirurgie Universitätsklinikum Frankfurt am Main
    • Mr.  Dr. med.  Georg  Jung 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsches Institut für Gefäßmedizinische Gesundheitsforschung (DIGG) gGmbH
    • Robert-Koch-Platz 9
    • 10115  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   030280990990
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.