CONFESS
Research type
Research Study
Full title
Treatment of common femoral artery atherosclerotic disease using an interwoven nitinol stent (Supera) – the CONFESS study.
IRAS ID
274726
Contact name
Hany Zayed
Contact email
Sponsor organisation
Guy's & St Thomas' Foundation NHS Trust R&D Department
Clinicaltrials.gov Identifier
274726, IRAS
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Summary of Research
This study will seek to address whether a new minimally invasive technology (interwoven nitinol stent i.e. the Supera device) can be used to treat a narrow femoral artery, which is the main vessel supplying blood to someone's leg. Narrowings of the femoral artery are a common cause for claudication (pain when walking) or leg amputations due to poor circulation. This new mininally invasive alternative to the standard open surgery could provide a solution for patients who are too unfit for surgery. However, we do not know whether the treatment is applicable to the types of patients with narrow femoral arteries that present for treatment in the NHS and what the doctors think about this new technology.
Research Aim
The primary aim of this research is to generate the necessary information that will allow us to understand whether the Supera device (a new minimally invasive treatment) can be used as an alternative to the current gold-standard of care in patients with atherosclerotic disease of their Common Femoral Artery (CFA) i.e. CFA Endarterectomy (CFAE).
Research Design
We will access existing anonymised patient information in two NHS hospitals to assess how many of our patients in the last 5 years would be eligible for treatment with this new technology. We will then conduct interviews and an online survey of doctors to assess what problems we may encounter if we start using this treatment routinely and whether we can perform a large randomised (national) study to assess this treatment in the future.
Summary of Results
: Our research team would like to first thank the study participants for their interest and involvement on the study called Treatment of common femoral artery atherosclerotic disease using an interwoven nitinol stent (Supera) - CONFESS study.
The study was carried out as a collaboration between Guy's and St Thomas' NHS Foundation Trust and the Department of Cardiovascular Sciences, University of Leicester. The study was funded by a research grant from Abbott Medical which had no input in the data analysis. The study was independently sponsored by Guy's and St Thomas' NHS Foundation Trust.
The reason behind conducting this study was to determine how to possibly conduct a high quality randomised controlled trial comparing open surgery and endovascular (keyhole) treatments of the Common Femoral Artery (CFA) disease. For the first (qualitative) component of our study we have conducted an online survey and face to face interviews with healthcare professionals to better understand perceptions about both treatment modalities and explore potential barriers and facilitators surrounding such trials. For the second (quantitative) component of our study we have described in detail the features of diseases in the arteries that were treated with open surgery (CFA endarterectomy) from January 2014 to December 2018 and tried to determine which ones would have been eligible for endovascular treatment.
This was a retrospective analysis and therefore there was no change in the standard of care the patient received. Our participants have not undergone any harm or adverse events.
As a result of our study we have discovered and highlighted several considerations to be taken into account when designing and delivering a randomised controlled trial regarding the choice of treatment for the CFA. It has helped all the involved and the medical community of interest to understand the next obstacles to overtake when proceeding with the much-needed trial.
The study results have been accepted in different national and international conferences. We have also submitted our results for publication in peer-reviewed vascular journals to ensure the widest possible dissemination.
Data from our study can be requested from the authors as needed.REC name
London - Bromley Research Ethics Committee
REC reference
20/LO/0059
Date of REC Opinion
21 Apr 2020
REC opinion
Further Information Favourable Opinion