Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease (OERESRD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293589|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
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.
|Condition or disease||Intervention/treatment|
|End-stage Renal Disease Critical Limb Ischemia||Procedure: open revascularization Procedure: endovascular revascularization|
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 Type :||Observational|
|Estimated Enrollment :||77 participants|
|Official Title:||Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia|
|Actual Study Start Date :||July 1, 2017|
|Primary Completion Date :||September 20, 2017|
|Estimated Study Completion Date :||October 2017|
patients treated with open revascularization
Procedure: open revascularization
surgical revascularization (i.e. Bypass surgery)
patients treated with endovascular revascularization
Procedure: endovascular revascularization
endovascular revascularization (stent, ballon angioplasty)
- Amputation free survival [ Time Frame: 24 months ]Evaluation of limb salvage and survival as Composite endpoint
- Overall survival [ Time Frame: 24 months ]Evaluation of Overall survival rate
- Major Amputation [ Time Frame: 24 months ]Evaluation of Major Amputation rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293589
|Contact: Alexander Meyer, MD||0049 9131 85 firstname.lastname@example.org|
|Erlangen, Bavaria, Germany, 91054|
|Contact: Alexander Meyer, MD 0049 09131 85 32968 email@example.com|
|Principal Investigator:||Alexander Meyer, MD||University Hospital Erlangen, Department of Vascular Sugery|