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CompletedNCT03293589OERESRDUpdated Mar 26, 2020

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

An observational study in End-stage Renal Disease and Critical Limb Ischemia, sponsored by University Hospital Erlangen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University Hospital Erlangen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
77
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • End-stage Renal Disease
  • Critical Limb Ischemia

Keywords

  • end-stage renal disease
  • critical limb ischemia
  • surgical revascularisation
  • endovascular therapy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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

Exclusion Criteria:

  • conservative Treatment
  • non-atherosclerotic lesions
  • coagulation disorders
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
77 participants (actual)
Patient registry
No

Groups and cohorts

  • OR

    patients treated with open revascularization

    Procedure: open revascularization

  • EVT

    patients treated with endovascular revascularization

    Procedure: endovascular revascularization

Interventions

  • Procedureopen revascularization

    surgical revascularization (i.e. Bypass surgery)

  • Procedureendovascular revascularization

    endovascular revascularization (stent, ballon angioplasty)

05

What researchers measure

Primary outcomes

  1. Amputation free survival

    Evaluation of limb salvage and survival as Composite endpoint

    Time frame: 24 months

Secondary outcomes

  1. Overall survival

    Evaluation of Overall survival rate

    Time frame: 24 months

  2. Major Amputation

    Evaluation of Major Amputation rate

    Time frame: 24 months

06

Study locations

1 site
  • University Hospital
    Erlangen, Bavaria 91054, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293589
Lead sponsor
University Hospital Erlangen
Responsible party
Alexander Meyer, MD (MD, University Hospital Erlangen) — Principal investigator
First posted
Sep 26, 2017
Start date
Jul 1, 2017
Primary completion
Sep 20, 2017
Completion
Oct 30, 2017
Last update
Mar 26, 2020

Study contacts

Alexander Meyer, MD
principal investigator · University Hospital Erlangen, Department of Vascular Sugery

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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