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

NCT03098290 | Completed DMC

• 4 other identifiers: VF1_2016-02801VSF1600801VSF18035DRKS00014649
• Study Type: observational
• Target: 5,608
• Locations: 1 country
• Sites: 35

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.

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

Outcome Measures

Primary Outcomes (24)

• 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)

Study Arms (3)

Intermittent Claudication

Mild to severe claudication

Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy

Ischaemic Rest Pain

Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy

Critical Limb Threatening Ischaemia

Ulcers, Necrosis, Gangrene

Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy

Interventions

Catheter-based endovascular revascularization PROCEDURE

(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)

Also known as: ER

Critical Limb Threatening Ischaemia; Intermittent Claudication; Ischaemic Rest Pain

Bypass-Surgery PROCEDURE

Venous or alloplastic or comparable Bypass

Also known as: Bypass

Critical Limb Threatening Ischaemia; Intermittent Claudication; Ischaemic Rest Pain

Endarterectomy PROCEDURE

Endarterectomy, Patchplasty

Also known as: TEA

Critical Limb Threatening Ischaemia; Intermittent Claudication; Ischaemic Rest Pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• GermanVasc: collaborator
• University Heart Center Hamburg: collaborator
• BARMER GEK Germany: collaborator
• University of Hamburg-Eppendorf: collaborator

Study Sites (35)

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)

Bad Krozingen, Germany

Location

Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Location

Asklepios Klinik Birkenwerder

Birkenwerder, Germany

Location

St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum

Bochum, Germany

Location

Gemeinschaftskrankenhaus Bonn, Haus St. Petrus

Bonn, Germany

Location

GFO Kliniken Bonn, Betriebsstätte St. Marien

Bonn, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Location

Carl-Thiem-Klinikum Cottbus

Cottbus, Germany

Location

Klinikum Darmstadt GmbH

Darmstadt, Germany

Location

Städtisches Klinikum Dresden Friedrichstadt

Dresden, Germany

Location

University Medical Center Düsseldorf

Düsseldorf, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)

Freiburg im Breisgau, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

Agaplesion Diakonieklinikum Hamburg

Hamburg, Germany

Location

SRH-Klinikum-Karlsbad-Langensteinbach

Karlsbach, Germany

Location

Klinikum Karlsruhe

Karlsruhe, Germany

Location

Agaplesion Diakonie Kliniken Kassel

Kassel, Germany

Location

St. Bonifatius Hospital Lingen

Lingen, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Germany

Location

Klinikum Magdeburg gGmbH

Magdeburg, Germany

Location

Theresienkrankenhaus Mannheim

Mannheim, Germany

Location

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

Location

Ev. Krankenhaus Mühlheim an der Ruhr

Mühlheim, Germany

Location

Isarklinikum München

München, Germany

Location

Klinikum Peine

Peine, Germany

Location

Imland Kliniken Rendsburg

Rendsburg, Germany

Location

Klinikum Rheine I Mathias Spital

Rheine, Germany

Location

Klinikum Stadt Soest

Soest, Germany

Location

Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)

Trier, Germany

Location

Related Publications (17)

• 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.

  PMID: 29230514 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29079875 BACKGROUND

• 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.

  PMID: 28715513 BACKGROUND

• 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.

  PMID: 29776646 BACKGROUND

• 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.

  PMID: 29856270 BACKGROUND

• 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.

  PMID: 32088069 BACKGROUND

• 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.

  PMID: 31526633 BACKGROUND

• 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.

  PMID: 31208079 BACKGROUND

• 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.

  PMID: 31121613 BACKGROUND

• 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.

  PMID: 31128987 BACKGROUND

• 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.

  PMID: 30113269 BACKGROUND

• 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.

  PMID: 31983289 RESULT

• 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.

  PMID: 31926836 RESULT

• 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.

  PMID: 31744786 RESULT

• 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.

  PMID: 34279120 RESULT

• 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.

  PMID: 36972814 DERIVED

Related Links

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

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Coronary Artery Bypass; Endarterectomy; Tea

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christian-Alexander Behrendt, Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: March 31, 2017
• Study Start: May 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: April 1, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

DE (35)