Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-stage Renal Disease
- Sponsor
- University Hospital Erlangen
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Amputation free survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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)
Investigators
Alexander Meyer, MD
MD
University Hospital Erlangen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Amputation free survival
Time Frame: 24 months
Evaluation of limb salvage and survival as Composite endpoint
Secondary Outcomes
- Major Amputation(24 months)
- Overall survival(24 months)