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

NCT03293589 | Completed

• 1 other identifier: 00042158
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease; Critical Limb Ischemia

Keywords

end-stage renal disease; critical limb ischemia; surgical revascularisation; endovascular therapy

Outcome Measures

Primary Outcomes (1)

• Amputation free survival

  Evaluation of limb salvage and survival as Composite endpoint

  24 months

Secondary Outcomes (2)

• Overall survival

  24 months

• Major Amputation

  24 months

Study Arms (2)

OR

patients treated with open revascularization

Procedure: open revascularization

EVT

patients treated with endovascular revascularization

Procedure: endovascular revascularization

Interventions

open revascularization PROCEDURE

surgical revascularization (i.e. Bypass surgery)

OR

endovascular revascularization PROCEDURE

endovascular revascularization (stent, ballon angioplasty)

EVT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• conservative Treatment
• non-atherosclerotic lesions
• coagulation disorders

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

University Hospital

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Ischemia

Study Officials

• Alexander Meyer, MD

  University Hospital Erlangen, Department of Vascular Sugery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: July 1, 2017
• Primary Completion: September 20, 2017
• Study Completion: October 30, 2017
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)