End-stage Renal DiseaseOERESRDNCT03293589
Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease
An observational study of End-stage Renal Disease and Critical Limb Ischemia, run by University Hospital Erlangen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-stage Renal Disease, Critical Limb Ischemia
- What is being tested?
- open revascularization and endovascular revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- conservative Treatment
- non-atherosclerotic lesions
- coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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)
- Conditions
- End-stage Renal Disease, Critical Limb Ischemia
- Being tested
- open revascularization, endovascular revascularization
- Keywords
- end-stage renal disease, critical limb ischemia, surgical revascularisation, endovascular therapy
- Medical subject headings
- Kidney Failure, Chronic, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open revascularizationProcedure or surgery
surgical revascularization (i.e. Bypass surgery)
endovascular revascularizationProcedure or surgery
endovascular revascularization (stent, ballon angioplasty)
| Study group | Role | What they receive |
|---|---|---|
| OR | patients treated with open revascularization Receives: Procedure: open revascularization | |
| EVT | patients treated with endovascular revascularization Receives: Procedure: endovascular revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation free survival
Evaluation of limb salvage and survival as Composite endpoint
Measured: 24 months
Secondary outcomes (2)
Overall survival
Evaluation of Overall survival rate
Measured: 24 months
Major Amputation
Evaluation of Major Amputation rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jul 2017
- Primary completion20 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Meyer, MD, University Hospital Erlangen
- Investigators
- Alexander Meyer, MD, Principal investigator, University Hospital Erlangen, Department of Vascular Sugery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293589
- Sponsor's protocol ID
- 00042158
- Acronym
- OERESRD
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT03293589
- Acronym / sponsor ID
- OERESRD / 00042158
- Conditions
- End-stage Renal Disease, Critical Limb Ischemia
- Keywords
- end-stage renal disease, critical limb ischemia, surgical revascularisation, endovascular therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR | – | Procedure: open revascularizationpatients treated with open revascularization |
| EVT | – | Procedure: endovascular revascularizationpatients treated with endovascular revascularization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- conservative Treatment
- non-atherosclerotic lesions
- coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open revascularizationsurgical revascularization (i.e. Bypass surgery) | Procedure or surgery | OR |
| endovascular revascularizationendovascular revascularization (stent, ballon angioplasty) | Procedure or surgery | EVT |
Primary outcome
Amputation free survival
Time frame: 24 months
Evaluation of limb salvage and survival as Composite endpoint
2 secondary outcomes
Overall survival
Time frame: 24 months
Major Amputation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for End-stage Renal Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Meyer, MD principal investigator
University Hospital Erlangen, Department of Vascular Sugery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease and Critical Limb Ischemia, run by University Hospital Erlangen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.