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Trial record 2 of 706 for:    Alexander Disease

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

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ClinicalTrials.gov Identifier: NCT03293589
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Alexander Meyer, MD, 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.


Condition or disease Intervention/treatment
End-stage Renal Disease Critical Limb Ischemia Procedure: open revascularization Procedure: endovascular revascularization

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 Type : Observational
Estimated Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Primary Completion Date : September 20, 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
OR
patients treated with open revascularization
Procedure: open revascularization
surgical revascularization (i.e. Bypass surgery)

EVT
patients treated with endovascular revascularization
Procedure: endovascular revascularization
endovascular revascularization (stent, ballon angioplasty)




Primary Outcome Measures :
  1. Amputation free survival [ Time Frame: 24 months ]
    Evaluation of limb salvage and survival as Composite endpoint


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    Evaluation of Overall survival rate

  2. Major Amputation [ Time Frame: 24 months ]
    Evaluation of Major Amputation rate



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
study Population comprises of all dialysis patients treated for critical limb ischemia by means of surgical or endiovascular Intervention at University Hospital Erlangen between 2009 and 2017
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Alexander Meyer, MD 0049 9131 85 32968 alexander.meyer@uk-erlangen.de

Locations
Germany
University Hospital Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Alexander Meyer, MD    0049 09131 85 32968    alexander.meyer@uk-erlangen.de   
Sponsors and Collaborators
University Hospital Erlangen
Investigators
Principal Investigator: Alexander Meyer, MD University Hospital Erlangen, Department of Vascular Sugery

Responsible Party: Alexander Meyer, MD, MD, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT03293589     History of Changes
Other Study ID Numbers: 00042158
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexander Meyer, MD, University Hospital Erlangen:
end-stage renal disease
critical limb ischemia
surgical revascularisation
endovascular therapy

Additional relevant MeSH terms:
Ischemia
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency