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OpenTrials
Completed

NCT Number: NCT03293589

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

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.

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Key information

Conditions

End-stage Renal Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Ischemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Erlangen, Bavaria, 91054, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

open revascularization

Procedure

surgical revascularization (i.e. Bypass surgery)

Endovascular Revascularization

Procedure

endovascular revascularization (stent, ballon angioplasty)

Primary outcomes

  1. Amputation free survival

    Time frame: 24 months

    Evaluation of limb salvage and survival as Composite endpoint

Secondary outcomes

  1. Overall survival

    Time frame: 24 months

    Evaluation of Overall survival rate

  2. Major Amputation

    Time frame: 24 months

    Evaluation of Major Amputation rate

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study title

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

Acronym: OERESRD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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