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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Symptomatic Peripheral Arterial Disease, Occlusive Disease of Artery of Lower Extremity, Quality of Life

Intervention / Treatment
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* Procedure: Catheter-based endovascular revascularization
* Procedure: Bypass-Surgery
* Procedure: Endarterectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intermittent Claudication<br>Mild to severe claudication | Procedure: Catheter-based endovascular revascularization<br>* (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)<br>* Other names: ER;Procedure: Bypass-Surgery<br>* Venous or alloplastic or comparable Bypass<br>* Other names: Bypass;Procedure: Endarterectomy<br>* Endarterectomy, Patchplasty<br>* Other names: TEA;|
| Ischaemic Rest Pain<br> | Procedure: Catheter-based endovascular revascularization<br>* (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)<br>* Other names: ER;Procedure: Bypass-Surgery<br>* Venous or alloplastic or comparable Bypass<br>* Other names: Bypass;Procedure: Endarterectomy<br>* Endarterectomy, Patchplasty<br>* Other names: TEA;|
| Critical Limb Threatening Ischaemia<br>Ulcers, Necrosis, Gangrene | Procedure: Catheter-based endovascular revascularization<br>* (e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)<br>* Other names: ER;Procedure: Bypass-Surgery<br>* Venous or alloplastic or comparable Bypass<br>* Other names: Bypass;Procedure: Endarterectomy<br>* Endarterectomy, Patchplasty<br>* Other names: TEA;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GermanVasc, Peripheral Arterial Disease, IDOMENEO, Routine Data, Registry Data, Data Validity