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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)

NCT03098290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5608

Last updated 2022-12-22

No results posted yet for this study

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.

Conditions

  • Symptomatic Peripheral Arterial Disease
  • Occlusive Disease of Artery of Lower Extremity
  • Quality of Life

Interventions

PROCEDURE

Catheter-based endovascular revascularization

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

PROCEDURE

Bypass-Surgery

Venous or alloplastic or comparable Bypass

PROCEDURE

Endarterectomy

Endarterectomy, Patchplasty

Sponsors & Collaborators

  • GermanVasc

    collaborator OTHER

  • University Heart Center Hamburg

    collaborator UNKNOWN

  • BARMER GEK Germany

    collaborator UNKNOWN

  • University of Hamburg-Eppendorf

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Christian-Alexander Behrendt, Dr. · Universitätsklinikum Hamburg-Eppendorf

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-03-31
Completion
2021-04-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098290 on ClinicalTrials.gov