Clinical trial NCT03098290: IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)
Official title: IDOMENEO: Multimethodical and Multistage Registry-based Longitudinal Study Project to Collect Primary Registry Data and Health Insurance Claims Data of Patients Invasively Treated for Peripheral Artery Disease (PAD) in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Peripheral Arterial Disease
Occlusive Disease of Artery of Lower Extremity
Quality of Life
Keywords: GermanVasc
Peripheral Arterial Disease
IDOMENEO
Routine Data
Registry Data
Data Validity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: GermanVasc
name: University Heart Center Hamburg
name: BARMER GEK Germany
name: University of Hamburg-Eppendorf
First posted: 2017-03-31
Enrollment: 5608
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic peripheral artery disease (PAD) treated invasively at certified multidisciplinary vascular centres in Germany.

Brief summary: The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular procedures for treatment are increasing worldwide. For many cases of treatment or procedures no randomized controlled trials (RCT) or results from meta-analyses are so far available. The decision for treatment and selection of procedure is therefore not uncommonly left up to the personal expertise of the physician. The IDOMENEO study represents a multistage multimethodological project for healthcare research and quality assurance in interdisciplinary vascular medicine, which undertakes a comprehensive examination of this topic. Various methods and data sources (even routine data) are linked in a meaningful way. The essential components of the total project are implementation of a register platform (GermanVasc), which conforms to data protection and data security as well as the development of instruments for valid measurement of the quality of life of patients with PAD. The data protection-conform linking of primary data in the register and routine data of the consortium partner BARMER should also enable validation of the data sources.


Eligibility criteria: Inclusion Criteria:

* Symptomatic peripheral artery disease (intermittent claudication or critical limb ischemia)
* Invasive treatment (open-surgical or endovascular)
* Informed consent was obtained

Exclusion Criteria:

* No informed consent was obtained
* Acute limb ischemia without any chronic symptomatic PAD

Primary outcomes:
measure: All-cause Mortality
timeFrame: 12 Months
measure: Lower Extremity Amputation
timeFrame: 12 Months
measure: Amputation-free Survival
timeFrame: 12 Months
measure: Patency of Revascularization
timeFrame: 12 Months
measure: Quality of Life (SF12, WIQ)
timeFrame: 12 Months
measure: Ambulation
timeFrame: 12 Months
measure: Myocardial infarction
timeFrame: 12 Months
measure: Stroke or TIA
timeFrame: 12 Months
measure: Stent or Graft Thrombosis
timeFrame: 12 Months
measure: Functional Status
timeFrame: 12 Months
measure: Modified Rutherford Classification
timeFrame: 12 Months
measure: Foot Infection
timeFrame: 12 Months
measure: Tissue Loss
timeFrame: 12 Months
measure: New Revascularization
timeFrame: 12 Months
measure: Major Adverse Cardiovascular Events (MACE, MACCE)
timeFrame: 12 Months
measure: Major Adverse Limb Events (MALE)
timeFrame: 12 Months
measure: Surgical Site Infection
timeFrame: 12 Months
measure: Major Bleeding Complication
timeFrame: 12 Months
measure: Acute kidney injury (AKI) requiring hemodialysis
timeFrame: At time of discharge (in-hospital period)
measure: Ankle-Brachial-Index
timeFrame: 12 Months
measure: Occurrence of target vessel dissection
timeFrame: At time of discharge (in-hospital period)
measure: Compartment Syndrome
timeFrame: At time of discharge (in-hospital period)
measure: Graft or Device Failure
timeFrame: At time of discharge (in-hospital period)
measure: Distal Embolisation
timeFrame: At time of discharge (in-hospital period)
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Bevensen
country: Germany
facility: Herz- und Gefäßzentrum Bad Bevensen
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Birkenwerder
country: Germany
facility: Asklepios Klinik Birkenwerder
city: Bochum
country: Germany
facility: St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum
city: Bonn
country: Germany
facility: Gemeinschaftskrankenhaus Bonn, Haus St. Petrus
city: Bonn
country: Germany
facility: GFO Kliniken Bonn, Betriebsstätte St. Marien
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden Friedrichstadt
city: Düsseldorf
country: Germany
facility: University Medical Center Düsseldorf
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Hamburg
country: Germany
facility: Agaplesion Diakonieklinikum Hamburg
city: Karlsbach
country: Germany
facility: SRH-Klinikum-Karlsbad-Langensteinbach
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
city: Kassel
country: Germany
facility: Agaplesion Diakonie Kliniken Kassel
city: Lingen
country: Germany
facility: St. Bonifatius Hospital Lingen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
city: Mannheim
country: Germany
facility: Theresienkrankenhaus Mannheim
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Mühlheim
country: Germany
facility: Ev. Krankenhaus Mühlheim an der Ruhr
city: München
country: Germany
facility: Isarklinikum München
city: Peine
country: Germany
facility: Klinikum Peine
city: Rendsburg
country: Germany
facility: Imland Kliniken Rendsburg
city: Rheine
country: Germany
facility: Klinikum Rheine I Mathias Spital
city: Soest
country: Germany
facility: Klinikum Stadt Soest
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christian-Alexander Behrendt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behrendt CA, Riess H, Harter M, Kriston L, Federrath H, Marschall U, Debus ES. [Guideline recommendations and quality indicators for invasive treatment of peripheral arterial disease in Germany : The IDOMENEO study for quality improvement and research in vascular medicine]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Feb;61(2):218-223. doi: 10.1007/s00103-017-2676-9. German.
citation: Behrendt CA, Härter M, Kriston L, Federrath H, Marschall U, Straub C, Debus ES. [IDOMENEO - Does treatment reality in vascular medicine conform to guidelines and treatment?] Gefaesschirurgie. 2017;22(1):41-47.
citation: Behrendt CA, Pridohl H, Schaar K, Federrath H, Debus ES. [Clinical registers in the twenty-first century : Balancing act between data protection and feasibility?]. Chirurg. 2017 Nov;88(11):944-949. doi: 10.1007/s00104-017-0542-9. German.
citation: Behrendt CA, Heidemann F, Haustein K, Grundmann RT, Debus ES; PSI Collaborators. Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers. Gefasschirurgie. 2017;22(Suppl 1):17-27. doi: 10.1007/s00772-016-0202-2. Epub 2016 Oct 28.
citation: Behrendt CA, Bertges D, Eldrup N, Beck AW, Mani K, Venermo M, Szeberin Z, Menyhei G, Thomson I, Heller G, Wigger P, Danielsson G, Galzerano G, Lopez C, Altreuther M, Sigvant B, Riess HC, Sedrakyan A, Beiles B, Bjorck M, Boyle JR, Debus ES, Cronenwett J. International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection. Eur J Vasc Endovasc Surg. 2018 Aug;56(2):217-237. doi: 10.1016/j.ejvs.2018.04.006. Epub 2018 May 30.
citation: Riess HC, Debus ES, Schwaneberg T, Hischke S, Maier J, Bublitz M, Kriston L, Harter M, Marschall U, Zeller T, Schellong SM, Behrendt CA. Indicators of outcome quality in peripheral arterial disease revascularisations - a Delphi expert consensus. Vasa. 2018 Oct;47(6):491-497. doi: 10.1024/0301-1526/a000720. Epub 2018 Jun 1.
citation: Behrendt CA, Peters F, Mani K. The Swinging Pendulum of Evidence: Is There a Reality Behind Results from Randomised Trials and Real World Data? Lessons Learned from the Paclitaxel Debate. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):510-511. doi: 10.1016/j.ejvs.2020.01.029. Epub 2020 Feb 20. No abstract available.
citation: Hischke S, Riess HC, Bublitz MK, Kriston L, Schwaneberg T, Harter M, Bertges D, S Debus E, Behrendt CA. Quality Indicators in Peripheral Arterial Occlusive Disease Treatment: A Systematic Review. Eur J Vasc Endovasc Surg. 2019 Nov;58(5):738-745. doi: 10.1016/j.ejvs.2019.06.029. Epub 2019 Sep 13.
citation: Kaschwich M, Behrendt CA, Heydecke G, Bayer A, Debus ES, Seedorf U, Aarabi G. The Association of Periodontitis and Peripheral Arterial Occlusive Disease-A Systematic Review. Int J Mol Sci. 2019 Jun 15;20(12):2936. doi: 10.3390/ijms20122936.
citation: Behrendt CA, Schwaneberg T, Hischke S, Muller T, Petersen T, Marschall U, Debus S, Kriston L. Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach. Gesundheitswesen. 2020 Mar;82(S 02):S94-S100. doi: 10.1055/a-0883-5098. Epub 2019 May 23.
citation: Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B; Acute Limb Ischaemia Collaborators. Editor's Choice - Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2019 Jun;57(6):816-821. doi: 10.1016/j.ejvs.2019.02.023. Epub 2019 May 22.
citation: Debus ES, Kriston L, Schwaneberg T, Hischke S, Riess HC, Harter M, Marschall U, Federrath H, Behrendt CA. Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry. Vasa. 2018 Oct;47(6):499-505. doi: 10.1024/0301-1526/a000730. Epub 2018 Aug 16.
citation: Aarabi G, Raedel M, Kreutzburg T, Hischke S, Debus ES, Marschall U, Seedorf U, Behrendt CA. Periodontal treatment and peripheral arterial disease severity - a retrospective analysis of health insurance claims data. Vasa. 2020 Mar;49(2):128-132. doi: 10.1024/0301-1526/a000846. Epub 2020 Jan 27.
citation: Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.
citation: Kreutzburg T, Peters F, Riess HC, Hischke S, Marschall U, Kriston L, L'Hoest H, Sedrakyan A, Debus ES, Behrendt CA. Editor's Choice - Comorbidity Patterns Among Patients with Peripheral Arterial Occlusive Disease in Germany: A Trend Analysis of Health Insurance Claims Data. Eur J Vasc Endovasc Surg. 2020 Jan;59(1):59-66. doi: 10.1016/j.ejvs.2019.08.006. Epub 2019 Nov 16.
citation: Kotov A, Peters F, Debus ES, Zeller T, Heider P, Stavroulakis K, Remig J, Gussmann A, Hoffmann J, Friedrich O, Nolte T, Behrendt CA. The prospective GermanVasc cohort study. Vasa. 2021 Nov;50(6):446-452. doi: 10.1024/0301-1526/a000966. Epub 2021 Jul 19.