Creating a registry of data of patients who have undergone endovascular reconstruction for aortic occlusive disease to assess treatment outcomes

ISRCTN ISRCTN19619299
DOI https://doi.org/10.1186/ISRCTN19619299
Secondary identifying numbers COBRA_01
Submission date
29/04/2020
Registration date
05/05/2020
Last edited
05/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Narrowing or blockages in the major arteries (aorto-iliac occlusive disease) can cause reduced blood flow to areas of the body leading to symptoms of pain (especially on movement) and tissue death (gangrene).

This is currently treated in Europe primarily using keyhole surgery techniques. These techniques are referred to as endovascular surgery. This may involve inserting a stent to keep the artery open for sufficient blood flow. The patient outcomes of these new techniques in treating blocked major arteries in the body are not well known.

Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) is a technique described to treat extensive aorto-iliac occlusive disease, especially in high risk patients. Despite promising outcomes from three years of research in cohorts from single hospitals, there is a lack of published results from other centres being able to reproduce these outcomes of this technique. Additionally, there are not currently results comparing the use of stent grafts (covered stents) and Bare Metal Stenting (BMS) for the endovascular treatment of aorto-iliac disease.

This study will look at the fate of patients who had this kind of treatment in many centres across Europe. The study aims to provide an understanding of what problems patients face following the surgeries and how optimal treatment can be provided.

Who can participate?
Information will be collected from patients who received treatment for aorto-iliac occlusive disease using endovascular surgery.

What does the study involve?
This is an observational trial. Patients will receive standard clinical care as per local policies and physicians' preference, and will not be required to attend any additional follow-up beyond standard care.

What are the possible benefits and risks of participating?
Only patients who have already had their surgery will be reported as part of this study. This project will have absolutely no impact on the clinical care of patients. No identifiable information will be collected and reported. There are no risks of participating as essentially the clinical care remains exactly the same.

Where is the study run from?
1. Guy's and St Thomas' NHS Foundation Trust (UK)
2. Leicester Vascular Institute (UK)
3. St Franziskus Hospital Münster (German)

When is the study starting and how long is it expected to run for?
Information for patients who had their surgery from May 2016 to April 2020 will be collected and reported

Who is funding the study?
This study is investigator-initiated and funded

Who is the main contact?
Dr Hany Zayed
hany.zayed@gstt.nhs.uk

Contact information

Mr Hany Zayed
Scientific

Vascular Surgery Department
St Thomas' Hospital
Westminster Road, 1st floor
London
SE1 7EH
United Kingdom

ORCiD logoORCID ID 0000-0001-5023-5834
Phone +44 02071887188
Email hany.zayed@gstt.nhs.uk

Study information

Study designInternational multicentre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleCovered Stents vs Bare Metal Stent Endovascular Reconstruction for Aortic Occlusive Disease (COBRA registry)
Study acronymCOBRA Registry
Study objectivesTo describe the short and medium-term outcomes following Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) and compare these with the performance of Bare Metal Stenting (BMS) reconstructions in a multicentre registry.
Ethics approval(s)1. NHS ethics approval not required as per HRA opinion March 2020, this registry does not impact on the pathway of clinical care and no identifiable data are collected. This is an observational study. Each centre outside the United Kingdom should seek all relevant approvals as per their local/national policies before commencing data collection of any description.
2. Ethical approval will be sought locally in Germany (St. Franziskus Hospital in Muenster) but this had been delayed due to the current public health emergency.
Health condition(s) or problem(s) studiedAortoiliac steno-occlusive arterial disease with ischaemic pain at rest or when walking (claudication) or tissue loss (gangrene)
InterventionThis is an observational trial using retrospective data. Patients will receive standard clinical care as per best available evidence, local/regional/national care pathways, and physicians' preference using CERAB/endovascular treatment of aorto-iliac disease using a combination of covered stents and BMS in the aorta. Patients will not have any additional follow up, assessment or reporting to the investigators beyond standard clinical care. The surgical techniques and stents used, as well as patient outcome data, will be collected from clinician notes. No patient identifiable data will be collected or communicated.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)A variety of BMSs and covered stents may be used as per local policies and physicians' preferences.
Primary outcome measureRe-intervention-free-survival, defined as the composite endpoint of target lesion revascularization (TLR) and/or death, whichever occurred first, obtained from clinician notes collected at day of discharge from hospital, 30 days after the procedure, and latest available follow-up.
Secondary outcome measuresThe following outcome measures will be obtained from clinician notes, collected at day of discharge from hospital, 30 days after the procedure, and latest available follow-up
1. Acute technical success
2. 30-days morbidity
3. 30-days mortality
4. Overall mortality
5. Conversion-to-surgery free time
6. Re-intervention free time
Overall study start date01/02/2020
Completion date30/04/2021

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsObservational study - no actual target.
Key inclusion criteria1. Infrarenal chronic aorto-iliac occlusive/stenotic symptomatic disease for >14 Days
2. Treatment by an aortic stent graft or bare metal stent with or without iliac stenting
Key exclusion criteria1. Acute aortic occlusive disease
2. Aneurysm related interventions
3. Previous aorto-iliac stenting or In-Stent-Restenosis
4. Aortic coarctation
5. Isolated Kissing-Stent-Reconstruction without aortic stents
6. Aortic injury/trauma related interventions
7. Suprarenal/visceral segment reconstructions
Date of first enrolment01/05/2016
Date of final enrolment30/04/2020

Locations

Countries of recruitment

  • Belgium
  • England
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study participating centres

Guy's and St Thomas' NHS Foundation Trust
Vascular Surgery Department
St Thomas' Hospital
Westminster Road, 1st floor
London
SE1 7EH
United Kingdom
St Franziskus Hospital Münster
Department of Vascular Surgery
Hohenzollernring 70
Münster
48145
Germany
Leicester Vascular Institute
Glenfield Hospital
Groby Road
Leicester
LR3 9QP
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust
Hospital/treatment centre

St Thomas' Hospital
Vascular Surgery Department North Wing
Westminster Bridge Road
London
SE1 7EH
England
United Kingdom

Phone +44 02071887188
Email R&D@gstt.nhs.uk
Website http://www.guysandstthomas.nhs.uk/Home.aspx
ROR logo "ROR" https://ror.org/00j161312
St. Franziskus Hospital
Hospital/treatment centre

Hohenzollernring 70
Münster
48145
Germany

Phone +49 0251 9350
Email stavroulakis.konstantinos@yahoo.gr
Website http://www.sfh-muenster.de/uk/home.html
ROR logo "ROR" https://ror.org/051nxfa23

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date30/01/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPublication and dissemination intended in peer-reviewed journal, conferences, and online media.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

01/05/2020: Trial’s existence confirmed by University Hospitals of Leicester Department of Audit and Service Provision.