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

March 25, 2020 updated by: Alexander Meyer, MD, University Hospital Erlangen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputation free survival
Time Frame: 24 months
Evaluation of limb salvage and survival as Composite endpoint
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
Evaluation of Overall survival rate
24 months
Major Amputation
Time Frame: 24 months
Evaluation of Major Amputation rate
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Investigators

  • Principal Investigator: Alexander Meyer, MD, University Hospital Erlangen, Department of Vascular Sugery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

September 20, 2017

Study Completion (ACTUAL)

October 30, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (ACTUAL)

September 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00042158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End-stage Renal Disease

Clinical Trials on open revascularization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe