The RAF Trial
Research type
Research Study
Full title
A RAndomised controlled trial assessing the clinical and cost-effectiveness of Endovascular vs. Open revascularisation for common Femoral artery steno-occlusive disease. The RAF Trial.
IRAS ID
341975
Contact name
Athanasios Saratzis
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
One in five people over 55 have narrowing or blockages in the arteries carrying blood to the legs. Poor blood flow can cause pain, ulcers or gangrene and may lead to amputation. The common femoral artery, in the groin, is often affected. For many years, doctors have treated this problem with open surgery. Although effective, open surgery can cause wound infection, pain and longer hospital stays. Keyhole surgery is now used more often in the NHS. It is less invasive, can be done under local anaesthetic and may reduce complications and improve recovery. However, we do not know whether open or keyhole surgery gives better results or value.
This randomised controlled trial will compare open and keyhole surgery for common femoral artery disease. The main aim is to find out which treatment is better at preventing major amputation, death and further leg procedures. The study will also compare quality of life, complications, recovery and NHS costs.
Twenty-four NHS hospitals serving diverse ethnic, social and economic communities will take part. Patients who agree to join the study will be allocated by chance to receive either open or keyhole surgery. All participants will be followed for at least one year, and outcomes will be compared between the two groups.
Patients and the public have helped shape this study. A national survey of 141 people with artery problems identified important research priorities. Also, 51 patients with femoral artery disease and 121 NHS experts helped design the trial and choose the outcomes that matter most. Two patients are formal members of the research team. An independent patient advisory group will meet during the study.
The NIHR Race Equality Framework will help ensure fair representation. Results will be shared through patient updates, social media, a public event, NHS decision makers and a free-to-access medical journal.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
26/SW/0068
Date of REC Opinion
1 Jul 2026
REC opinion
Further Information Favourable Opinion