IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)
NCT ID: NCT03098290
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5608 participants
OBSERVATIONAL
2018-05-01
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intermittent Claudication
Mild to severe claudication
Catheter-based endovascular revascularization
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Bypass-Surgery
Venous or alloplastic or comparable Bypass
Endarterectomy
Endarterectomy, Patchplasty
Ischaemic Rest Pain
Catheter-based endovascular revascularization
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Bypass-Surgery
Venous or alloplastic or comparable Bypass
Endarterectomy
Endarterectomy, Patchplasty
Critical Limb Threatening Ischaemia
Ulcers, Necrosis, Gangrene
Catheter-based endovascular revascularization
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Bypass-Surgery
Venous or alloplastic or comparable Bypass
Endarterectomy
Endarterectomy, Patchplasty
Interventions
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Catheter-based endovascular revascularization
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Bypass-Surgery
Venous or alloplastic or comparable Bypass
Endarterectomy
Endarterectomy, Patchplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Invasive treatment (open-surgical or endovascular)
* Informed consent was obtained
Exclusion Criteria
* Acute limb ischemia without any chronic symptomatic PAD
ALL
No
Sponsors
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GermanVasc
OTHER
University Heart Center Hamburg
UNKNOWN
BARMER GEK Germany
UNKNOWN
University of Hamburg-Eppendorf
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Christian-Alexander Behrendt
Assoc. Prof. Dr.
Principal Investigators
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Christian-Alexander Behrendt, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Zentralklinik Bad Berka GmbH
Bad Berka, , Germany
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
Bad Krozingen, , Germany
Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Asklepios Klinik Birkenwerder
Birkenwerder, , Germany
St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum
Bochum, , Germany
Gemeinschaftskrankenhaus Bonn, Haus St. Petrus
Bonn, , Germany
GFO Kliniken Bonn, Betriebsstätte St. Marien
Bonn, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Carl-Thiem-Klinikum Cottbus
Cottbus, , Germany
Klinikum Darmstadt GmbH
Darmstadt, , Germany
Städtisches Klinikum Dresden Friedrichstadt
Dresden, , Germany
University Medical Center Düsseldorf
Düsseldorf, , Germany
HELIOS Klinikum Erfurt
Erfurt, , Germany
Elisabeth-Krankenhaus Essen
Essen, , Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
Freiburg im Breisgau, , Germany
Klinikum Fulda
Fulda, , Germany
University Heart Center Hamburg
Hamburg, , Germany
Agaplesion Diakonieklinikum Hamburg
Hamburg, , Germany
SRH-Klinikum-Karlsbad-Langensteinbach
Karlsbach, , Germany
Klinikum Karlsruhe
Karlsruhe, , Germany
Agaplesion Diakonie Kliniken Kassel
Kassel, , Germany
St. Bonifatius Hospital Lingen
Lingen, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, , Germany
Klinikum Magdeburg gGmbH
Magdeburg, , Germany
Theresienkrankenhaus Mannheim
Mannheim, , Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, , Germany
Ev. Krankenhaus Mühlheim an der Ruhr
Mühlheim, , Germany
Isarklinikum München
München, , Germany
Klinikum Peine
Peine, , Germany
Imland Kliniken Rendsburg
Rendsburg, , Germany
Klinikum Rheine I Mathias Spital
Rheine, , Germany
Klinikum Stadt Soest
Soest, , Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)
Trier, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Peters F, Behrendt CA; IDOMENEO Collaborators. Limb Related Outcomes of Endovascular vs. Open Surgical Revascularisation in Patients with Peripheral Arterial Occlusive Disease: A Report from the Prospective GermanVasc Cohort Study. Eur J Vasc Endovasc Surg. 2023 Jul;66(1):85-93. doi: 10.1016/j.ejvs.2023.03.040. Epub 2023 Mar 25.
Related Links
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Project website (German)
Website of the research group leading the project
Other Identifiers
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01VSF16008
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
01VSF18035
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DRKS00014649
Identifier Type: OTHER
Identifier Source: secondary_id
VF1_2016-028
Identifier Type: -
Identifier Source: org_study_id