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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,608
- 试验地点
- 34
- 主要终点
- Distal Embolisation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic peripheral artery disease (intermittent claudication or critical limb ischemia)
- •Invasive treatment (open-surgical or endovascular)
- •Informed consent was obtained
排除标准
- •No informed consent was obtained
- •Acute limb ischemia without any chronic symptomatic PAD
结局指标
主要结局
Distal Embolisation
时间窗: At time of discharge (in-hospital period)
All-cause Mortality
时间窗: 12 Months
Death from any reason
Graft or Device Failure
时间窗: At time of discharge (in-hospital period)
Ambulation
时间窗: 12 Months
Lower Extremity Amputation
时间窗: 12 Months
Amputation of lower extremity
Compartment Syndrome
时间窗: At time of discharge (in-hospital period)
Myocardial infarction
时间窗: 12 Months
Functional Status
时间窗: 12 Months
New Revascularization
时间窗: 12 Months
Major Bleeding Complication
时间窗: 12 Months
Acute kidney injury (AKI) requiring hemodialysis
时间窗: At time of discharge (in-hospital period)
As defined by the National Kidney Foundation.
Stent or Graft Thrombosis
时间窗: 12 Months
Modified Rutherford Classification
时间窗: 12 Months
Amputation-free Survival
时间窗: 12 Months
Long-term-survival without any major amputation
Patency of Revascularization
时间窗: 12 Months
Patency of treated vessel
Stroke or TIA
时间窗: 12 Months
Foot Infection
时间窗: 12 Months
Quality of Life (SF12, WIQ)
时间窗: 12 Months
Combined questionnaire including 26 questions using QoL-SF12 and Walking Impairment Questionnaire
Tissue Loss
时间窗: 12 Months
Surgical Site Infection
时间窗: 12 Months
Ankle-Brachial-Index
时间窗: 12 Months
Major Adverse Cardiovascular Events (MACE, MACCE)
时间窗: 12 Months
Major Adverse Limb Events (MALE)
时间窗: 12 Months
Occurrence of target vessel dissection
时间窗: At time of discharge (in-hospital period)
Any new dissection of the target vessel related to the procedure
次要结局
未报告次要终点
研究者
Christian-Alexander Behrendt
Assoc. Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf