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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)

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ClinicalTrials.gov Identifier: NCT03098290
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : April 14, 2020
Sponsor:
Collaborators:
GermanVasc
University Heart Center Hamburg
BARMER GEK Germany
University of Hamburg
Information provided by (Responsible Party):
Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment
Symptomatic Peripheral Arterial Disease Occlusive Disease of Artery of Lower Extremity Quality of Life Procedure: Catheter-based endovascular revascularization Procedure: Bypass-Surgery Procedure: Endarterectomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


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 Name: ER

Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Name: Bypass

Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Name: 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 Name: ER

Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Name: Bypass

Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Name: 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 Name: ER

Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Name: Bypass

Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Name: TEA




Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic peripheral artery disease (PAD) treated invasively at certified multidisciplinary vascular centres in Germany.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098290


Contacts
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Contact: Christian-Alexander Behrendt, Dr. +49-40-7410-18087 ch.behrendt@uke.de
Contact: Nicol Splawinski +49-40-7410-35679 info@idomeneo.de

Locations
Show Show 43 study locations
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
GermanVasc
University Heart Center Hamburg
BARMER GEK Germany
University of Hamburg
Investigators
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Principal Investigator: Christian-Alexander Behrendt, Dr. Universitätsklinikum Hamburg-Eppendorf
Additional Information:
Publications of Results:
Other Publications:
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.

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Responsible Party: Christian Behrendt, Dr., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03098290    
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 )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf:
GermanVasc
Peripheral Arterial Disease
IDOMENEO
Routine Data
Registry Data
Data Validity
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases