Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease

Study Overview
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Brief Summary
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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
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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)

Official Title
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Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia

Conditions
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End-stage Renal Disease, Critical Limb Ischemia

Intervention / Treatment
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* Procedure: open revascularization
* Procedure: endovascular revascularization


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OR<br>patients treated with open revascularization | Procedure: open revascularization<br>* surgical revascularization (i.e. Bypass surgery)<br>|
| EVT<br>patients treated with endovascular revascularization | Procedure: endovascular revascularization<br>* endovascular revascularization (stent, ballon angioplasty)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival | Evaluation of limb salvage and survival as Composite endpoint | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Evaluation of Overall survival rate | 24 months | 
| Major Amputation | Evaluation of Major Amputation rate | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal disease, critical limb ischemia, surgical revascularisation, endovascular therapy