IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)
- Conditions
- Occlusive Disease of Artery of Lower ExtremitySymptomatic Peripheral Arterial DiseaseQuality of Life
- Interventions
- Procedure: Catheter-based endovascular revascularizationProcedure: Bypass-SurgeryProcedure: Endarterectomy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5608
- Symptomatic peripheral artery disease (intermittent claudication or critical limb ischemia)
- Invasive treatment (open-surgical or endovascular)
- Informed consent was obtained
- No informed consent was obtained
- Acute limb ischemia without any chronic symptomatic PAD
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intermittent Claudication Bypass-Surgery Mild to severe claudication Ischaemic Rest Pain Endarterectomy - Ischaemic Rest Pain Catheter-based endovascular revascularization - Intermittent Claudication Catheter-based endovascular revascularization Mild to severe claudication Intermittent Claudication Endarterectomy Mild to severe claudication Ischaemic Rest Pain Bypass-Surgery - Critical Limb Threatening Ischaemia Catheter-based endovascular revascularization Ulcers, Necrosis, Gangrene Critical Limb Threatening Ischaemia Bypass-Surgery Ulcers, Necrosis, Gangrene Critical Limb Threatening Ischaemia Endarterectomy Ulcers, Necrosis, Gangrene
- Primary Outcome Measures
Name Time Method Stroke or TIA 12 Months 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Gemeinschaftskrankenhaus Bonn, Haus St. Petrus
🇩🇪Bonn, Germany
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, 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
GFO Kliniken Bonn, Betriebsstätte St. Marien
🇩🇪Bonn, Germany
Carl-Thiem-Klinikum Cottbus
🇩🇪Cottbus, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Klinikum Darmstadt GmbH
🇩🇪Darmstadt, Germany
Städtisches Klinikum Dresden Friedrichstadt
🇩🇪Dresden, Germany
University Medical Center Düsseldorf
🇩🇪Düsseldorf, Germany
HELIOS Klinikum Erfurt
🇩🇪Erfurt, Germany
Elisabeth-Krankenhaus Essen
🇩🇪Essen, Germany
Klinikum Fulda
🇩🇪Fulda, Germany
University Heart Center Hamburg
🇩🇪Hamburg, Germany
Agaplesion Diakonieklinikum Hamburg
🇩🇪Hamburg, Germany
SRH-Klinikum-Karlsbad-Langensteinbach
🇩🇪Karlsbach, Germany
Agaplesion Diakonie Kliniken Kassel
🇩🇪Kassel, Germany
Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
St. Bonifatius Hospital Lingen
🇩🇪Lingen, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Klinikum Magdeburg gGmbH
🇩🇪Magdeburg, Germany
Theresienkrankenhaus Mannheim
🇩🇪Mannheim, Germany
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Germany
Ev. Krankenhaus Mühlheim an der Ruhr
🇩🇪Mühlheim, Germany
Isarklinikum München
🇩🇪München, Germany
Imland Kliniken Rendsburg
🇩🇪Rendsburg, Germany
Klinikum Peine
🇩🇪Peine, Germany
Klinikum Rheine I Mathias Spital
🇩🇪Rheine, Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH (Mitte)
🇩🇪Trier, Germany
Klinikum Stadt Soest
🇩🇪Soest, Germany
Herz- und Gefäßzentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany