A study comparing minimally invasive (endovascular) treatment and open surgery to improve blood flow in the groin (femoral) artery
| ISRCTN | ISRCTN12861037 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12861037 |
| Integrated Research Application System (IRAS) | 341975 |
| Central Portfolio Management System (CPMS) | 61599 |
| National Institute for Health and Care Research (NIHR) | 167450 |
| Sponsor | University of Leicester |
| Funder | National Institute for Health and Care Research |
- Submission date
- 24/04/2026
- Registration date
- 08/06/2026
- Last edited
- 08/06/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
One in five people over 55 years have blockages in arteries carrying blood to the legs. Poor blood flow due to these blockages can cause leg pain or gangrene. When someone has these symptoms, they need an operation to improve blood flow. This is done by opening up the blocked arteries. The leg artery that most often needs unblocking is an artery in the groin called the femoral artery. Doctors have been treating narrowed or blocked femoral arteries with open surgery for years. This open surgery often leads to problems like wound infections, pain, and a long stay in hospital. Recently, keyhole surgery has been developed for such cases, which is less invasive, performed under local anaesthetic, and might lead to fewer complications and better quality of life. Keyhole surgery is now often performed in the NHS for diseased femoral arteries. Unfortunately, we don’t know whether open or keyhole surgery is better. Both surgeries have pros and cons. By finding out which is better, we may be able to reduce the number of amputations, deaths, and additional surgeries for people with femoral artery disease. Also, we will find out which surgery costs the NHS less money.
This study will check whether open or keyhole surgery of the common femoral artery is better at preventing amputations, deaths, and additional leg surgeries. We will also check the quality of life of people taking part and which type of surgery is cheaper for the NHS.
Who can participate?
Patients aged 18 years and over with chronic limb-threatening ischemia (CLTI) who are suitable for open or endovascular methods of revascularisation.
What does the study involve?
Participants will be randomly allocated to open or endovascular treatment. After their procedure, a follow-up period will assess their clinical outcomes, quality of life and cost-effectiveness of the care received. The follow-up period lasts a maximum of 36 months post-procedure with a minimum follow-up period of 12 months.
What are the possible benefits and risks of participating?
Taking part may offer several possible benefits. Participants will receive either open surgery or minimally invasive (endovascular) treatment, both of which are standard treatments already used in the NHS. They will be closely monitored by a specialist vascular team, with regular follow-up to check recovery, blood flow to the leg, and quality of life. The information collected may help doctors understand which treatment works best, which could improve care for future patients with peripheral arterial disease.
There are also possible risks. As with any operation or procedure, complications can occur. Open surgery may involve a larger cut, more pain, wound infection, or a longer stay in hospital. Minimally invasive treatment is less invasive but may not last as long, and some people may need further procedures in the future. Taking part may also involve extra clinic visits or questionnaires. All risks will be explained before participation.
Where is the study run from?
1. University Hospitals of Leicester (UK)
2. University of Leicester (UK)
When is the study starting and how long is expected to run for?
July 2026 to November 2029
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) (UK)
Who is the main contact?
1. Prof. Athanasios Saratzis, as875@leicester.ac.uk
2. Study mailbox, RAFtrial@leicester.ac.uk
Contact information
Public, Scientific, Principal investigator
Glenfield Hospital, Cardiovascular Research Centre
Groby Road
Leicester
LE39QP
United Kingdom
| Phone | +44 (0)1162523190 |
|---|---|
| as875@leicester.ac.uk |
Public
Leicester Clinical Trials Unit, University of Leicester, Maurice Shock Building, University Road
Leicester
LE1 7RH
United Kingdom
| Phone | +44 (0)116 252 3027 |
|---|---|
| li29@leicester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific 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 |
| Study acronym | RAF |
| Study objectives | Primary objective: Identify whether open surgery for CFA disease is superior to endovascular treatment in terms of death and re-interventions (including major amputation or arterial revascularisation) over a minimum 1-year follow-up in a time-to-event analysis. Secondary objectives: 1. Estimate differences in quality of life of patients between arms. 2. Estimate differences in quality-adjusted life years (QALYs) and costs between two arms. 3. Evaluate the incremental cost-effectiveness ratios in terms of clinical improvement and QALYs gained of the intervention group compared with the control group. |
| Ethics approval(s) |
Submitted 23/04/2026, South Central - Oxford B Research Ethics Committee (N/A, Oxford, N/A, United Kingdom; N/A; oxfordb.rec@hra.nhs.uk), ref: 26/SC/0158 |
| Health condition(s) or problem(s) studied | Revascularisation for common femoral artery steno-occlusive disease |
| Intervention | Randomisation is 1:1 and performed through a web-based service called Sealed Envelope. Participants are randomised to undergo either open surgery or endovascular treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Composite of death (all-cause) and/or reintervention (major amputation or lower limb revascularisation) is measured over a minimum of 1 year (time-to-event analysis). Major amputation is defined as any amputation above the level of the ankle joint in the ipsilateral lower limb. Revascularisation is defined as any arterial revascularisation in the ipsilateral lower limb. |
| Key secondary outcome measure(s) |
1. Quality of life measured using the EuroQOL-5D (EQ-5D-5L) score at baseline and months 6, 12, 24 and 36 |
| Completion date | 30/11/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 504 |
| Key inclusion criteria | 1. Age >=18 years 2. Chronic limb-threatening ischemia (CLTI) (rest pain and/or tissue loss) or severe lifestyle-limiting claudication (Rutherford Stage >=3 or Fontaine Stage >=IIb) 3. Patient deemed suitable for common femoral artery (CFA) open surgery or endovascular treatment by the treating clinicians (pragmatic design) For participants with bilateral disease, the leg with more severe symptoms will be designated as the trial leg, as per other RCTs. Adjunctive inflow/outflow procedures will be permitted, with decisions regarding these left to the discretion of operators (pragmatic design). |
| Key exclusion criteria | 1. Asymptomatic peripheral artery disease (PAD) 2. Pregnancy |
| Date of first enrolment | 01/07/2026 |
| Date of final enrolment | 30/06/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centre
Leicester
LE1 5WW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
24/04/2026: Study's existence confirmed by the NIHR.
