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

Quality of Life Clinical Trial

— IDOMENEO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098290
• Other study ID #: VF1_2016-028
• Secondary ID: 01VSF1600801VSF1
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5608
• Est. completion date: April 1, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Occlusive Disease of Artery of Lower Extremity
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Quality of Life
• Symptomatic Peripheral Arterial Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Germany	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
Germany	Klinikum Fulda	Fulda
Germany	Agaplesion Diakonieklinikum Hamburg	Hamburg
Germany	University Heart Center 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

Sponsors (5)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	BARMER GEK Germany, GermanVasc, University Heart Center Hamburg, University of Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (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: 10.10 — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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 Propens — View 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. — View 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. — View 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. — View 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. — View 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 Ins — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

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

External Links

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