Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Hany Zayed
ORCID ID
http://orcid.org/0000-0001-5023-5834
Contact details
Vascular Surgery Department
St Thomas' Hospital
Westminster Road
1st floor
London
SE1 7EH
United Kingdom
+44 02071887188
hany.zayed@gstt.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
COBRA_01
Study information
Scientific title
Covered Stents vs Bare Metal Stent Endovascular Reconstruction for Aortic Occlusive Disease (COBRA registry)
Acronym
COBRA Registry
Study hypothesis
To 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
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.
Study design
International multicentre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Aortoiliac steno-occlusive arterial disease with ischaemic pain at rest or when walking (claudication) or tissue loss (gangrene)
Intervention
This 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 type
Device
Phase
Not Applicable
Drug names
A variety of BMSs and covered stents may be used as per local policies and physicians' preferences.
Primary outcome measure
Re-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 measures
The 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 trial start date
01/02/2020
Overall trial end date
30/04/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Observational study - no actual target.
Participant exclusion criteria
1. 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
Recruitment start date
01/05/2016
Recruitment end date
30/04/2020
Locations
Countries of recruitment
Belgium, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
Vascular Surgery Department
St Thomas' Hospital
Westminster Road, 1st floor
London
SE1 7EH
United Kingdom
Trial participating centre
St Franziskus Hospital Münster
Department of Vascular Surgery
Hohenzollernring 70
Münster
48145
Germany
Trial participating centre
Leicester Vascular Institute
Glenfield Hospital
Groby Road
Leicester
LR3 9QP
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
St Thomas' Hospital
Vascular Surgery Department North Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 02071887188
R&D@gstt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
http://www.guysandstthomas.nhs.uk/Home.aspx
Organisation
St. Franziskus Hospital
Sponsor details
Hohenzollernring 70
Münster
48145
Germany
+49 0251 9350
stavroulakis.konstantinos@yahoo.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication and dissemination intended in peer-reviewed journal, conferences, and online media.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/01/2023
Participant level data
Not expected to be available
Basic results (scientific)
Publication list