Critical Limb Ischemia, End-stage Renal Disease
Conditions
Keywords
end-stage renal disease, critical limb ischemia, surgical revascularisation, endovascular therapy
Brief summary
Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these patients. Most optimal vascular therapy mode has not been finally decided in these patients. Therefore retrospective analysis of patients receiving open surgical and endovascular revascularisation was performed.
Detailed description
Query of internal clinical database for identification of patients (2009-2017)with end-stage renal disease and critical limb ischemia, receiving either open surgical (Group I OR) or endovascular revascularisation (Group II EVT). Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral run-off, plantar arch) and comorbidities. Prospective follow-up of identified patients by means of telephone contacts and/or clinical examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free survival, wound healing)
Interventions
surgical revascularization (i.e. Bypass surgery)
endovascular revascularization (stent, ballon angioplasty)
Sponsors
Study design
Eligibility
Inclusion criteria
* presence of end-stage renal disease * presence of critical limb ischemia (Ankle-brachial-index \> 0.4 or presence of rest pain or ischemic ulcers or gangrene) * revascularisation by means of Bypass or endovascular therapy
Exclusion criteria
* conservative Treatment * non-atherosclerotic lesions * coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amputation free survival | 24 months | Evaluation of limb salvage and survival as Composite endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | Evaluation of Overall survival rate |
| Major Amputation | 24 months | Evaluation of Major Amputation rate |
Countries
Germany