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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

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

Treatments: Procedure: Endarterectomy; Procedure: Catheter-based endovascular revascularization; Procedure: Bypass-Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03098290

VF1_2016-028

01VSF16008 (Other Grant/Funding Number)

DRKS00014649 (Other Identifier)

01VSF18035 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 5,608 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

5,608 participants in 3 patient groups

Intermittent Claudication

Description:

Mild to severe claudication

Treatment:

Procedure: Bypass-Surgery

Procedure: Catheter-based endovascular revascularization

Procedure: Endarterectomy

Ischaemic Rest Pain

Treatment:

Procedure: Bypass-Surgery

Procedure: Catheter-based endovascular revascularization

Procedure: Endarterectomy

Critical Limb Threatening Ischaemia

Description:

Ulcers, Necrosis, Gangrene

Treatment:

Procedure: Bypass-Surgery

Procedure: Catheter-based endovascular revascularization

Procedure: Endarterectomy