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

NCT ID: NCT03293589

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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End-stage Renal Disease Critical Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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OR

patients treated with open revascularization

open revascularization

Intervention Type PROCEDURE

surgical revascularization (i.e. Bypass surgery)

EVT

patients treated with endovascular revascularization

endovascular revascularization

Intervention Type PROCEDURE

endovascular revascularization (stent, ballon angioplasty)

Interventions

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open revascularization

surgical revascularization (i.e. Bypass surgery)

Intervention Type PROCEDURE

endovascular revascularization

endovascular revascularization (stent, ballon angioplasty)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Erlangen

OTHER

Sponsor Role lead

Responsible Party

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Alexander Meyer, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen, Department of Vascular Sugery

Locations

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University Hospital

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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00042158

Identifier Type: -

Identifier Source: org_study_id

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