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

Completed

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

• Registration Number: NCT03098290
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-26
• Study First Posted: 2017-03-31
• Study Start: 2018-05-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5608

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distal Embolisation	At time of discharge (in-hospital period)
Graft or Device Failure	At time of discharge (in-hospital period)
Myocardial infarction	12 Months
Functional Status	12 Months
New Revascularization	12 Months
Major Bleeding Complication	12 Months
Acute kidney injury (AKI) requiring hemodialysis	At time of discharge (in-hospital period)	As defined by the National Kidney Foundation.
Compartment Syndrome	At time of discharge (in-hospital period)
All-cause Mortality	12 Months	Death from any reason
Lower Extremity Amputation	12 Months	Amputation of lower extremity
Ambulation	12 Months
Stent or Graft Thrombosis	12 Months
Modified Rutherford Classification	12 Months
Amputation-free Survival	12 Months	Long-term-survival without any major amputation
Patency of Revascularization	12 Months	Patency of treated vessel
Stroke or TIA	12 Months
Foot Infection	12 Months
Quality of Life (SF12, WIQ)	12 Months	Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
Tissue Loss	12 Months
Surgical Site Infection	12 Months
Ankle-Brachial-Index	12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)	12 Months
Major Adverse Limb Events (MALE)	12 Months
Occurrence of target vessel dissection	At time of discharge (in-hospital period)	Any new dissection of the target vessel related to the procedure

Trial Locations

Locations (34)

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Herz- und Gefäßzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen (UHZ); 🇩🇪 Freiburg, Germany

Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Asklepios Klinik Birkenwerder; 🇩🇪 Birkenwerder, Germany

St. Josef Hospital I Katholisches Klinikum der Ruhr-Universität Bochum; 🇩🇪 Bochum, Germany

Gemeinschaftskrankenhaus Bonn, Haus St. Petrus; 🇩🇪 Bonn, Germany

GFO Kliniken Bonn, Betriebsstätte St. Marien; 🇩🇪 Bonn, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

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