Plain English Summary
Background and study aims
Severe limb ischaemia (SLI) is a growing problem in the UK, with one in every 1000-2000 people being diagnosed every year. SLI is a serious condition in which the arteries supplying limbs (most often the legs) with blood become narrowed or blocked due to the build-up of fatty substances (plaque). This often occurs around the knee in the femoral and popliteal arteries (femoropopliteal disease), which means that the lower parts of the limb (such as the feet) do not receive adequate blood supply (vascularisation). In SLI, small injuries to the feet are unable to heal, as they are not being supplied with enough oxygen rich blood. If left untreated, this can lead to ulcers, gangrene and ultimately death of the limb (necrosis). Once the limb “dies” the only available course of action is amputation, which can cause the sufferer a great deal of emotional distress. In recent years, more and more patients are undergoing surgery to improve blood supply to the leg (revascularisation) before amputation becomes the only option. An angioplasty is a common procedure in which a thin tube (catheter) is placed in the narrowed blood vessel. A small balloon on the tip of the catheter is gradually inflated to reopen the artery and flatten the blockage against the artery wall. In some cases, the surgeon may also insert a mesh-like tube (stent) into the artery to keep it open. These techniques are known as endovascular, as they take place inside the artery. In recent years, new techniques have been developed with incorporate drugs designed to stop the blockages coming back. These techniques can be very expensive however, and more research is needed to find out whether they are more effective in the long-term than traditional procedures. The aim of this study is to compare the effectiveness and cost-effectiveness of new endovascular techniques using drugs with traditional methods.
Who can participate?
Adults with severe limb ischaemia due to femoropopliteal disease, who are suitable for early revascularisation.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are given a plain balloon angioplasty (traditional method), in which a bare metal stent (stent without a coating) is also inserted if required. For those in the second group, the balloon used in the angioplasty procedure is coated in a drug (drug-coated balloon angioplasty) designed to prevent cells from multiplying (cell proliferation) and re-blocking the artery. During the angioplasty procedure, the medication on the balloon surface is deposited on the artery wall when the balloon inflates. Those in the third group have a drug-eluting stent (DES) placed in the artery, which is a stent that is coated in a drug that blocks cell proliferation. After their procedures, patients in all three groups are monitored to find out whether having the endovascular procedure has prevented the need for amputation.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Sixty hospitals in England, Scotland and Wales (UK)
When is the study starting and how long is it expected to run for?
November 2015 to February 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Hugh Jarrett
Mr Hugh Jarrett
The University of Birmingham
+44 121 415 8444
Multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia due to atherosclerotic femoro-popliteal, with or without infra-popliteal involvement, peripheral arterial disease
The aim of this study is to determine whether a drug coated balloon +/- bare metal stent or a drug eluting stent with plain balloon angioplasty or a bare metal stent are the most effective revascularisation strategy and the most clinically and cost-effective treatment strategy for severe limb ischaemia due to femoro-popliteal disease.
Randomised; Interventional; Design type: Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Atherothrombosis
Participants are randomly allocated to one of three treatment groups.
Group 1: Participants receive a plain balloon angioplasty with a bare metal stent (if needed)
Group 2: Participants receive a drug coated balloon with a bare metal stent (if needed)
Group 3: Participants receive a drug eluting stent
To fully capture this activity, as well as the associated changes in QoL and health resource usage, patients will be closely followed up, for a minimum of two years. Patients are asked to attend follow-up appointments at 1, 6, 12, 24 and 36 months. At each timepoint patients will be asked to complete questionnaires and some of their clinical data will be collected. After 3 years patients will be followed up for primary outcome only (i.e. if they are still alive and still have the trial limb).
Primary outcome measures
Amputation free survival (AFS) defined as the time to major limb (above the ankle) amputation of the index (trial) limb or death from any cause.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Aged 18 years or over
2. Have severe limb ischaemia due to femoro-popliteal, with or without infra-popliteal, peripheral artery disease
3. Be judged by the responsible clinicians (consultant vascular surgeon, interventional radiologist, diabetologist) working as part of a multidisciplinary team to require early endovascular femoro-popliteal, with or without infra-popliteal revascularisation in addition to best medical treatment, foot and wound care
4. Have adequate ‘inflow’ to support all possible trial revascularisation strategies
5. Be judged suitable for all possible trial revascularisation strategies following diagnostic imaging and a formal (documented) discussion by a multi-disciplinary team meeting
Target number of participants
Planned Sample Size: 861; UK Sample Size: 861
Participant exclusion criteria
1. Have an anticipated life expectancy <6 months
2. Are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity [Scotland] Act 2000)
3. Are a non-English speaker where translation facilities are insufficient to guarantee informed consent
4. Are judged unsuitable for any of the revascularisation strategies being evaluated
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Clinical Trials Unit
The University of Birmingham Edgbaston
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Papers will be published following the analysis of the data. A report to the HTA is required within 12 months of trial completion and will also be published.
Intention to publish date
Participant level data
Available on request
Results - basic reporting