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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5,608
- Locations
- 34
- Primary Endpoint
- Distal Embolisation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Distal Embolisation
Time Frame: At time of discharge (in-hospital period)
All-cause Mortality
Time Frame: 12 Months
Death from any reason
Graft or Device Failure
Time Frame: At time of discharge (in-hospital period)
Ambulation
Time Frame: 12 Months
Lower Extremity Amputation
Time Frame: 12 Months
Amputation of lower extremity
Compartment Syndrome
Time Frame: At time of discharge (in-hospital period)
Myocardial infarction
Time Frame: 12 Months
Functional Status
Time Frame: 12 Months
New Revascularization
Time Frame: 12 Months
Major Bleeding Complication
Time Frame: 12 Months
Acute kidney injury (AKI) requiring hemodialysis
Time Frame: At time of discharge (in-hospital period)
As defined by the National Kidney Foundation.
Stent or Graft Thrombosis
Time Frame: 12 Months
Modified Rutherford Classification
Time Frame: 12 Months
Amputation-free Survival
Time Frame: 12 Months
Long-term-survival without any major amputation
Patency of Revascularization
Time Frame: 12 Months
Patency of treated vessel
Stroke or TIA
Time Frame: 12 Months
Foot Infection
Time Frame: 12 Months
Quality of Life (SF12, WIQ)
Time Frame: 12 Months
Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
Tissue Loss
Time Frame: 12 Months
Surgical Site Infection
Time Frame: 12 Months
Ankle-Brachial-Index
Time Frame: 12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)
Time Frame: 12 Months
Major Adverse Limb Events (MALE)
Time Frame: 12 Months
Occurrence of target vessel dissection
Time Frame: At time of discharge (in-hospital period)
Any new dissection of the target vessel related to the procedure
Secondary Outcomes
No secondary outcomes reported
Investigators
Christian-Alexander Behrendt
Assoc. Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf