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

Completed

• Conditions: Critical Limb Ischemia; End-stage Renal Disease
• Interventions: Procedure: open revascularization; Procedure: endovascular revascularization

• Registration Number: NCT03293589
• Lead Sponsor: University Hospital Erlangen

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)

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-09-20
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Study Completion: 2017-10-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OR	open revascularization	patients treated with open revascularization
EVT	endovascular revascularization	patients treated with endovascular revascularization

Primary Outcome Measures

Name	Time	Method
Amputation free survival	24 months	Evaluation of limb salvage and survival as Composite endpoint

Secondary Outcome Measures

Name	Time	Method
Major Amputation	24 months	Evaluation of Major Amputation rate
Overall survival	24 months	Evaluation of Overall survival rate

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Erlangen, Bavaria, Germany