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

End-stage Renal Disease Clinical Trial

— OERESRD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293589
• Other study ID #: 00042158
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: March 2020
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 30, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• End-stage Renal Disease
• Ischemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• open revascularization
surgical revascularization (i.e. Bypass surgery)
• endovascular revascularization
endovascular revascularization (stent, ballon angioplasty)

Locations

Country	Name	City	State
Germany	University Hospital	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation free survival	Evaluation of limb salvage and survival as Composite endpoint	24 months
Secondary	Overall survival	Evaluation of Overall survival rate	24 months
Secondary	Major Amputation	Evaluation of Major Amputation rate	24 months