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Symptomatic Peripheral Arterial DiseaseIDOMENEONCT03098290

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

An observational study of Symptomatic Peripheral Arterial Disease and Occlusive Disease of Artery of Lower Extremity, run by Universitätsklinikum Hamburg-Eppendorf at 35 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Catheter-based endovascular revascularization, Bypass-Surgery and Endarterectomy
Type of treatment
Surgery or procedure
How many people
5,608 participants
Where
35 sitesGermany
Study dates
1 May 2018to 1 Apr 2021
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Germany35 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka

  • Herz- und Gefäßzentrum Bad Bevensen

    Bad Bevensen

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)

    Bad Krozingen

  • Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin

  • HELIOS Klinikum Berlin-Buch

    Berlin

  • Asklepios Klinik Birkenwerder

    Birkenwerder

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

    Bochum

  • Gemeinschaftskrankenhaus Bonn, Haus St. Petrus

    Bonn

  • GFO Kliniken Bonn, Betriebsstätte St. Marien

    Bonn

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Carl-Thiem-Klinikum Cottbus

    Cottbus

  • Klinikum Darmstadt GmbH

    Darmstadt

  • Städtisches Klinikum Dresden Friedrichstadt

    Dresden

  • University Medical Center Düsseldorf

    Düsseldorf

  • HELIOS Klinikum Erfurt

    Erfurt

  • Elisabeth-Krankenhaus Essen

    Essen

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)

    Freiburg im Breisgau

  • Klinikum Fulda

    Fulda

  • University Heart Center Hamburg

    Hamburg, 20246

  • Agaplesion Diakonieklinikum Hamburg

    Hamburg

  • SRH-Klinikum-Karlsbad-Langensteinbach

    Karlsbach

  • Klinikum Karlsruhe

    Karlsruhe

  • Agaplesion Diakonie Kliniken Kassel

    Kassel

  • St. Bonifatius Hospital Lingen

    Lingen

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Klinikum Magdeburg gGmbH

    Magdeburg

  • Theresienkrankenhaus Mannheim

    Mannheim

  • Kliniken Maria Hilf GmbH

    Mönchengladbach

  • Ev. Krankenhaus Mühlheim an der Ruhr

    Mühlheim

  • Isarklinikum München

    München

  • Klinikum Peine

    Peine

  • Imland Kliniken Rendsburg

    Rendsburg

  • Klinikum Rheine I Mathias Spital

    Rheine

  • Klinikum Stadt Soest

    Soest

  • Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)

    Trier

Other trials in Germany

About this study

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

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.

Being tested
Catheter-based endovascular revascularization, Bypass-Surgery, Endarterectomy
Keywords
GermanVasc, Peripheral Arterial Disease, IDOMENEO, Routine Data, Registry Data, Data Validity
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter-based endovascular revascularizationProcedure or surgery

    Also called ER

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

  • Bypass-SurgeryProcedure or surgery

    Also called Bypass

    Venous or alloplastic or comparable Bypass

  • EndarterectomyProcedure or surgery

    Also called TEA

    Endarterectomy, Patchplasty

Study groups in NCT03098290
Study groupRoleWhat they receive
Intermittent ClaudicationMild to severe claudication
Receives: Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy
Ischaemic Rest PainNot described
Receives: Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy
Critical Limb Threatening IschaemiaUlcers, Necrosis, Gangrene
Receives: Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery; Procedure: Endarterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality

    Death from any reason

    Measured: 12 Months

  2. Lower Extremity Amputation

    Amputation of lower extremity

    Measured: 12 Months

  3. Amputation-free Survival

    Long-term-survival without any major amputation

    Measured: 12 Months

  4. Patency of Revascularization

    Patency of treated vessel

    Measured: 12 Months

  5. Quality of Life (SF12, WIQ)

    Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire

    Measured: 12 Months

  6. Ambulation

    Measured: 12 Months

  7. Myocardial infarction

    Measured: 12 Months

  8. Stroke or TIA

    Measured: 12 Months

  9. Stent or Graft Thrombosis

    Measured: 12 Months

  10. Functional Status

    Measured: 12 Months

  11. Modified Rutherford Classification

    Measured: 12 Months

  12. Foot Infection

    Measured: 12 Months

  13. Tissue Loss

    Measured: 12 Months

  14. New Revascularization

    Measured: 12 Months

  15. Major Adverse Cardiovascular Events (MACE, MACCE)

    Measured: 12 Months

  16. Major Adverse Limb Events (MALE)

    Measured: 12 Months

  17. Surgical Site Infection

    Measured: 12 Months

  18. Major Bleeding Complication

    Measured: 12 Months

  19. Acute kidney injury (AKI) requiring hemodialysis

    As defined by the National Kidney Foundation.

    Measured: At time of discharge (in-hospital period)

  20. Ankle-Brachial-Index

    Measured: 12 Months

  21. Occurrence of target vessel dissection

    Any new dissection of the target vessel related to the procedure

    Measured: At time of discharge (in-hospital period)

  22. Compartment Syndrome

    Measured: At time of discharge (in-hospital period)

  23. Graft or Device Failure

    Measured: At time of discharge (in-hospital period)

  24. Distal Embolisation

    Measured: At time of discharge (in-hospital period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2017
  2. Study start1 May 2018
  3. Primary completion31 Mar 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,608 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098290
Sponsor's protocol ID
VF1_2016-028
Other IDs
01VSF16008, 01VSF18035, DRKS00014649
Acronym
IDOMENEO
Status last verified
Dec 2022
First submitted
26 Mar 2017
Last updated
22 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29230514

  • 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.

    PubMed 29079875

  • 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.

    PubMed 28715513

  • 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.

    PubMed 29776646

  • 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.

    PubMed 29856270

  • 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.

    PubMed 32088069

  • 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.

    PubMed 31526633

  • 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.

    PubMed 31208079

  • 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.

    PubMed 31121613

  • 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.

    PubMed 31128987

  • 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.

    PubMed 30113269

  • 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.

    PubMed 31983289

  • 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.

    PubMed 31926836

  • 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.

    PubMed 31744786

Questions about this trial

What is this clinical trial studying?

An observational study of Symptomatic Peripheral Arterial Disease and Occlusive Disease of Artery of Lower Extremity, run by Universitätsklinikum Hamburg-Eppendorf at 35 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: 12 Months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098290, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

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