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Completed

NCT Number: NCT03098290

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

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.

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Key information

Conditions

Symptomatic Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Occlusive Disease of Artery of Lower Extremity Peripheral Arterial Disease Peripheral Vascular Diseases Quality of Life Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentralklinik Bad Berka GmbH, Bad Berka, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter-based endovascular revascularization

Procedure

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

Other names: ER

Bypass-Surgery

Procedure

Venous or alloplastic or comparable Bypass

Other names: Bypass

Endarterectomy

Procedure

Endarterectomy, Patchplasty

Other names: TEA

Primary outcomes

  1. All-cause Mortality

    Time frame: 12 Months

    Death from any reason

  2. Lower Extremity Amputation

    Time frame: 12 Months

    Amputation of lower extremity

  3. Amputation-free Survival

    Time frame: 12 Months

    Long-term-survival without any major amputation

  4. Patency of Revascularization

    Time frame: 12 Months

    Patency of treated vessel

  5. Quality of Life (SF12, WIQ)

    Time frame: 12 Months

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

  6. Ambulation

    Time frame: 12 Months

  7. Myocardial infarction

    Time frame: 12 Months

  8. Stroke or TIA

    Time frame: 12 Months

  9. Stent or Graft Thrombosis

    Time frame: 12 Months

  10. Functional Status

    Time frame: 12 Months

  11. Modified Rutherford Classification

    Time frame: 12 Months

  12. Foot Infection

    Time frame: 12 Months

  13. Tissue Loss

    Time frame: 12 Months

  14. New Revascularization

    Time frame: 12 Months

  15. Major Adverse Cardiovascular Events (MACE, MACCE)

    Time frame: 12 Months

  16. Major Adverse Limb Events (MALE)

    Time frame: 12 Months

  17. Surgical Site Infection

    Time frame: 12 Months

  18. Major Bleeding Complication

    Time frame: 12 Months

  19. Acute kidney injury (AKI) requiring hemodialysis

    Time frame: At time of discharge (in-hospital period)

    As defined by the National Kidney Foundation.

  20. Ankle-Brachial-Index

    Time frame: 12 Months

  21. Occurrence of target vessel dissection

    Time frame: At time of discharge (in-hospital period)

    Any new dissection of the target vessel related to the procedure

  22. Compartment Syndrome

    Time frame: At time of discharge (in-hospital period)

  23. Graft or Device Failure

    Time frame: At time of discharge (in-hospital period)

  24. Distal Embolisation

    Time frame: At time of discharge (in-hospital period)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • BARMER GEK Germany
  • GermanVasc
  • University Heart Center Hamburg
  • University of Hamburg-Eppendorf

Registry information

Official study 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

Acronym: IDOMENEO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2017
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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