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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03098290
Recruitment Status : Not yet recruiting
First Posted : March 31, 2017
Last Update Posted : June 14, 2017
University Heart Center Hamburg
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
Peripheral Arterial Disease Occlusive Disease of Artery of Lower Extremity Quality of Life

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
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Endovascular Treatment
Patients treated for peripheral artery disease with endovascular techniques (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Open Surgical Treatment
Patients treated for peripheral artery disease with open-surgical techniques (e.g. Bypass-surgery, Thrombendarterectomy)

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. Vessel-patency [ Time Frame: 12 Months ]
    Patency of treated vessel

  5. Quality-of-Life [ Time Frame: 12 Months ]
  6. Major-Amputation [ 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. Deep Venous Thrombosis or Lung Embolism [ Time Frame: 12 Months ]
  11. Major Cardiovascular or Cerebrovascular or Limb Event [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT03098290

Contact: Christian-Alexander Behrendt, MD +49-40-7410-18087

Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
University Heart Center Hamburg
University of Hamburg

Responsible Party: Christian Behrendt, Dr., Universitätsklinikum Hamburg-Eppendorf Identifier: NCT03098290     History of Changes
Other Study ID Numbers: VF1_2016-028
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf:
Peripheral Arterial Disease
Routine Data
Registry Data
Data Validity

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases