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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03293589
Acronym
OERESRD
Enrollment
77
Registered
2017-09-26
Start date
2017-07-01
Completion date
2017-10-30
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, End-stage Renal Disease

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

PROCEDUREopen revascularization

surgical revascularization (i.e. Bypass surgery)

endovascular revascularization (stent, ballon angioplasty)

Sponsors

University Hospital Erlangen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Amputation free survival24 monthsEvaluation of limb salvage and survival as Composite endpoint

Secondary

MeasureTime frameDescription
Overall survival24 monthsEvaluation of Overall survival rate
Major Amputation24 monthsEvaluation of Major Amputation rate

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026