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)

December 21, 2022 updated by: Christian-Alexander Behrendt, Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5608

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany
        • Zentralklinik Bad Berka GmbH
      • Bad Bevensen, Germany
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Krozingen, Germany
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
      • Berlin, Germany
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany
        • Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
      • Birkenwerder, Germany
        • Asklepios Klinik Birkenwerder
      • Bochum, Germany
        • St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum
      • Bonn, Germany
        • Gemeinschaftskrankenhaus Bonn, Haus St. Petrus
      • Bonn, Germany
        • GFO Kliniken Bonn, Betriebsstätte St. Marien
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Cottbus, Germany
        • Carl-Thiem-Klinikum Cottbus
      • Darmstadt, Germany
        • Klinikum Darmstadt GmbH
      • Dresden, Germany
        • Städtisches Klinikum Dresden Friedrichstadt
      • Düsseldorf, Germany
        • University Medical Center Düsseldorf
      • Erfurt, Germany
        • HELIOS Klinikum Erfurt
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen
      • Freiburg, Germany
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ)
      • Fulda, Germany
        • Klinikum Fulda
      • Hamburg, Germany, 20246
        • University Heart Center Hamburg
      • Hamburg, Germany
        • Agaplesion Diakonieklinikum Hamburg
      • Karlsbach, Germany
        • SRH-Klinikum-Karlsbad-Langensteinbach
      • Karlsruhe, Germany
        • Klinikum Karlsruhe
      • Kassel, Germany
        • Agaplesion Diakonie Kliniken Kassel
      • Lingen, Germany
        • St. Bonifatius Hospital Lingen
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Magdeburg, Germany
        • Klinikum Magdeburg gGmbH
      • Mannheim, Germany
        • Theresienkrankenhaus Mannheim
      • Mönchengladbach, Germany
        • Kliniken Maria Hilf GmbH
      • Mühlheim, Germany
        • Ev. Krankenhaus Mühlheim an der Ruhr
      • München, Germany
        • Isarklinikum München
      • Peine, Germany
        • Klinikum Peine
      • Rendsburg, Germany
        • Imland Kliniken Rendsburg
      • Rheine, Germany
        • Klinikum Rheine I Mathias Spital
      • Soest, Germany
        • Klinikum Stadt Soest
      • Trier, Germany
        • Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • ER
Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Names:
  • Bypass
Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Names:
  • 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 Names:
  • ER
Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Names:
  • Bypass
Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Names:
  • 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 Names:
  • ER
Procedure: Bypass-Surgery
Venous or alloplastic or comparable Bypass
Other Names:
  • Bypass
Procedure: Endarterectomy
Endarterectomy, Patchplasty
Other Names:
  • TEA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: 12 Months
Death from any reason
12 Months
Lower Extremity Amputation
Time Frame: 12 Months
Amputation of lower extremity
12 Months
Amputation-free Survival
Time Frame: 12 Months
Long-term-survival without any major amputation
12 Months
Patency of Revascularization
Time Frame: 12 Months
Patency of treated vessel
12 Months
Quality of Life (SF12, WIQ)
Time Frame: 12 Months
Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
12 Months
Ambulation
Time Frame: 12 Months
12 Months
Myocardial infarction
Time Frame: 12 Months
12 Months
Stroke or TIA
Time Frame: 12 Months
12 Months
Stent or Graft Thrombosis
Time Frame: 12 Months
12 Months
Functional Status
Time Frame: 12 Months
12 Months
Modified Rutherford Classification
Time Frame: 12 Months
12 Months
Foot Infection
Time Frame: 12 Months
12 Months
Tissue Loss
Time Frame: 12 Months
12 Months
New Revascularization
Time Frame: 12 Months
12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)
Time Frame: 12 Months
12 Months
Major Adverse Limb Events (MALE)
Time Frame: 12 Months
12 Months
Surgical Site Infection
Time Frame: 12 Months
12 Months
Major Bleeding Complication
Time Frame: 12 Months
12 Months
Acute kidney injury (AKI) requiring hemodialysis
Time Frame: At time of discharge (in-hospital period)
As defined by the National Kidney Foundation.
At time of discharge (in-hospital period)
Ankle-Brachial-Index
Time Frame: 12 Months
12 Months
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
At time of discharge (in-hospital period)
Compartment Syndrome
Time Frame: At time of discharge (in-hospital period)
At time of discharge (in-hospital period)
Graft or Device Failure
Time Frame: At time of discharge (in-hospital period)
At time of discharge (in-hospital period)
Distal Embolisation
Time Frame: At time of discharge (in-hospital period)
At time of discharge (in-hospital period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Hamburg-Eppendorf
GermanVasc
University Heart Center Hamburg
BARMER GEK Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian-Alexander Behrendt, Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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