IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD) (IDOMENEO)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Occlusive Disease of Artery of Lower Extremity; Symptomatic Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy

• Study Type: Observational
• Enrollment (Actual): 5608

Contacts and Locations

Study Locations

• Germany
  • Bad Berka, Germany
    • Zentralklinik Bad Berka GmbH
  • Bad Bevensen, Germany
    • Herz- und Gefasszentrum Bad Bevensen
  • Bad Krozingen, Germany
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
  • Berlin, Germany
    • HELIOS Klinikum Berlin-Buch
  • Berlin, Germany
    • Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
  • Birkenwerder, Germany
    • Asklepios Klinik Birkenwerder
  • Bochum, Germany
    • St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum
  • Bonn, Germany
    • Gemeinschaftskrankenhaus Bonn, Haus St. Petrus
  • Bonn, Germany
    • GFO Kliniken Bonn, Betriebsstätte St. Marien
  • Chemnitz, Germany
    • Klinikum Chemnitz Ggmbh
  • Cottbus, Germany
    • Carl-Thiem-Klinikum Cottbus
  • Darmstadt, Germany
    • Klinikum Darmstadt GmbH
  • Dresden, Germany
    • Städtisches Klinikum Dresden Friedrichstadt
  • Düsseldorf, Germany
    • University Medical Center Düsseldorf
  • Erfurt, Germany
    • Helios Klinikum Erfurt
  • Essen, Germany
    • Elisabeth-Krankenhaus Essen
  • Freiburg, Germany
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
  • Fulda, Germany
    • Klinikum Fulda
  • Hamburg, Germany, 20246
    • University Heart Center Hamburg
  • Hamburg, Germany
    • Agaplesion Diakonieklinikum Hamburg
  • Karlsbach, Germany
    • SRH-Klinikum-Karlsbad-Langensteinbach
  • Karlsruhe, Germany
    • Klinikum Karlsruhe
  • Kassel, Germany
    • Agaplesion Diakonie Kliniken Kassel
  • Lingen, Germany
    • St. Bonifatius Hospital Lingen
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Magdeburg, Germany
    • Klinikum Magdeburg gGmbH
  • Mannheim, Germany
    • Theresienkrankenhaus Mannheim
  • Mönchengladbach, Germany
    • Kliniken Maria Hilf GmbH
  • Mühlheim, Germany
    • Ev. Krankenhaus Mühlheim an der Ruhr
  • München, Germany
    • Isarklinikum München
  • Peine, Germany
    • Klinikum Peine
  • Rendsburg, Germany
    • Imland Kliniken Rendsburg
  • Rheine, Germany
    • Klinikum Rheine I Mathias Spital
  • Soest, Germany
    • Klinikum Stadt Soest
  • Trier, Germany
    • Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic peripheral artery disease (PAD) treated invasively at certified multidisciplinary vascular centres in Germany.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intermittent Claudication; Mild to severe claudication	Procedure: Catheter-based endovascular revascularization; (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon); Other Names: ER; Procedure: Bypass-Surgery; Venous or alloplastic or comparable Bypass; Other Names: Bypass; Procedure: Endarterectomy; Endarterectomy, Patchplasty; Other Names: TEA
Ischaemic Rest Pain	Procedure: Catheter-based endovascular revascularization; (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon); Other Names: ER; Procedure: Bypass-Surgery; Venous or alloplastic or comparable Bypass; Other Names: Bypass; Procedure: Endarterectomy; Endarterectomy, Patchplasty; Other Names: TEA
Critical Limb Threatening Ischaemia; Ulcers, Necrosis, Gangrene	Procedure: Catheter-based endovascular revascularization; (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon); Other Names: ER; Procedure: Bypass-Surgery; Venous or alloplastic or comparable Bypass; Other Names: Bypass; Procedure: Endarterectomy; Endarterectomy, Patchplasty; Other Names: TEA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	Death from any reason	12 Months
Lower Extremity Amputation	Amputation of lower extremity	12 Months
Amputation-free Survival	Long-term-survival without any major amputation	12 Months
Patency of Revascularization	Patency of treated vessel	12 Months
Quality of Life (SF12, WIQ)	Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire	12 Months
Ambulation		12 Months
Myocardial infarction		12 Months
Stroke or TIA		12 Months
Stent or Graft Thrombosis		12 Months
Functional Status		12 Months
Modified Rutherford Classification		12 Months
Foot Infection		12 Months
Tissue Loss		12 Months
New Revascularization		12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)		12 Months
Major Adverse Limb Events (MALE)		12 Months
Surgical Site Infection		12 Months
Major Bleeding Complication		12 Months
Acute kidney injury (AKI) requiring hemodialysis	As defined by the National Kidney Foundation.	At time of discharge (in-hospital period)
Ankle-Brachial-Index		12 Months
Occurrence of target vessel dissection	Any new dissection of the target vessel related to the procedure	At time of discharge (in-hospital period)
Compartment Syndrome		At time of discharge (in-hospital period)
Graft or Device Failure		At time of discharge (in-hospital period)
Distal Embolisation		At time of discharge (in-hospital period)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: University of Hamburg-Eppendorf; GermanVasc; University Heart Center Hamburg; BARMER GEK Germany
• Investigators: Principal Investigator: Christian-Alexander Behrendt, Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Project website (German)
• Website of the research group leading the project

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: March 26, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; GermanVasc; IDOMENEO; Routine Data; Registry Data; Data Validity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: VF1_2016-028; 01VSF16008 (Other Grant/Funding Number: German Federal Joint Committee); 01VSF18035 (Other Grant/Funding Number: German Federal Joint Committee); DRKS00014649 (Other Identifier: German Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No