Occlusive Disease of Artery of Lower Extremity, Quality of Life, Symptomatic Peripheral Arterial Disease
Conditions
Keywords
GermanVasc, Peripheral Arterial Disease, IDOMENEO, Routine Data, Registry Data, Data Validity
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.
Interventions
PROCEDURECatheter-based endovascular revascularization
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
PROCEDUREBypass-Surgery
Venous or alloplastic or comparable Bypass
PROCEDUREEndarterectomy
Endarterectomy, Patchplasty
Sponsors
GermanVasc
University Heart Center Hamburg
BARMER GEK Germany
University of Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | 12 Months | Death from any reason |
| Lower Extremity Amputation | 12 Months | Amputation of lower extremity |
| Amputation-free Survival | 12 Months | Long-term-survival without any major amputation |
| Patency of Revascularization | 12 Months | Patency of treated vessel |
| Quality of Life (SF12, WIQ) | 12 Months | Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire |
| 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 | At time of discharge (in-hospital period) | As defined by the National Kidney Foundation. |
| Ankle-Brachial-Index | 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 |
| 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) | — |
Countries
Germany
Outcome results
None listed