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

U

University Hospital Erlangen

Status

Completed

Conditions

Critical Limb Ischemia
End-stage Renal Disease

Treatments

Procedure: endovascular revascularization
Procedure: open revascularization

Study type

Observational

Funder types

Other

Identifiers

NCT03293589
00042158

Details and patient eligibility

About

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.

Full 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)

Enrollment

77 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

77 participants in 2 patient groups

OR
Description:
patients treated with open revascularization
Treatment:
Procedure: open revascularization
EVT
Description:
patients treated with endovascular revascularization
Treatment:
Procedure: endovascular revascularization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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