An observational study in Symptomatic Peripheral Arterial Disease, Occlusive Disease of Artery of Lower Extremity and Quality of Life, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 35 sites in Germany. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's enrollment of 5,608 is above the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic peripheral artery disease (PAD) treated invasively at certified multidisciplinary vascular centres in Germany.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Mild to severe claudication
Procedure: Catheter-based endovascular revascularization · Procedure: Bypass-Surgery · Procedure: Endarterectomy
Procedure: Catheter-based endovascular revascularization · Procedure: Bypass-Surgery · Procedure: Endarterectomy
Ulcers, Necrosis, Gangrene
Procedure: Catheter-based endovascular revascularization · Procedure: Bypass-Surgery · Procedure: Endarterectomy
(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
Also known as: ER
Venous or alloplastic or comparable Bypass
Also known as: Bypass
Endarterectomy, Patchplasty
Also known as: TEA
All-cause Mortality
Death from any reason
Time frame: 12 Months
Lower Extremity Amputation
Amputation of lower extremity
Time frame: 12 Months
Amputation-free Survival
Long-term-survival without any major amputation
Time frame: 12 Months
Patency of Revascularization
Patency of treated vessel
Time frame: 12 Months
Quality of Life (SF12, WIQ)
Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
Time frame: 12 Months
Ambulation
Time frame: 12 Months
Myocardial infarction
Time frame: 12 Months
Stroke or TIA
Time frame: 12 Months
Stent or Graft Thrombosis
Time frame: 12 Months
Functional Status
Time frame: 12 Months
Modified Rutherford Classification
Time frame: 12 Months
Foot Infection
Time frame: 12 Months
Tissue Loss
Time frame: 12 Months
New Revascularization
Time frame: 12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)
Time frame: 12 Months
Major Adverse Limb Events (MALE)
Time frame: 12 Months
Surgical Site Infection
Time frame: 12 Months
Major Bleeding Complication
Time frame: 12 Months
Acute kidney injury (AKI) requiring hemodialysis
As defined by the National Kidney Foundation.
Time frame: At time of discharge (in-hospital period)
Ankle-Brachial-Index
Time frame: 12 Months
Occurrence of target vessel dissection
Any new dissection of the target vessel related to the procedure
Time frame: At time of discharge (in-hospital period)
Compartment Syndrome
Time frame: At time of discharge (in-hospital period)
Graft or Device Failure
Time frame: At time of discharge (in-hospital period)
Distal Embolisation
Time frame: At time of discharge (in-hospital period)
Plan to share: Undecided
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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