Vascular Completed Research

Patients presenting with a  dilation of the large abdominal artery, a so-called aneurysm of the abdominal aorta (AAA). The dilation in this blood vessel is caused by a weakening in the vessel wall. If left untreated, this bulge can continue to grow to a size that can affect other large arteries in the abdomen. Eventually the bulge can even tear, which is life-threatening. Treatment is aimed at preventing further growth and tearing. One of the accepted possibilities is to place a tube (stent graft) over the weak spot against the inside of the artery. The blood then flows through the stent graft so that the weak spot is spared. The Gore © Excluder © AAA Endoprosthesis is a new type of stent graft that has already received CE marking for treatment of an AAA. For this study, demographic data, surgical data and clinical data from patients who undergo a Gore © Excluder © AAA stent graft procedure will be collected over a period of up to 3 years.

Project Details
Principal Investigator: Mr Marcus Brooks
Planned End Date: 01/04/2025
Local Ref: 4230

Chronic venous ulceration are open wounds on the lower limbs which have been present for at least six months and are caused by a poorly functioning venous system. The affect about 1% of the general population and about 4% of those over 65. The wounds cause pain, reduced movement, and can smell - greatly affecting the quality of life of leg ulcer patients. The standard care for these patients is compression bandaging, which requires changing several times a week by community or district nurses; this drives the high cost of leg ulcer care, which can amount to £2.5 billion per annum.

Skin grafting can be used alongside compression bandaging and can help the ulcers heal faster than compression alone. Grafts can be taken from the patient’s own skin, from a donor or from tissue engineered skin. An autograft (using own skin) can cause scarring and the need for a formal surgical procedure in theatre so are not suitable for all ulcer patients. Allografts (donor skin) and xenografts (animal skin) have been used successfully, but present similar drawbacks to autografts, plus the potential for the body to reject the graft and disease transmission. Tissue engineered skin has several advantages as it has been processed to remove the cells, and therefore is won't be rejected via the immune response. Human decellularised dermis (DCD) is generated from donated skin from deceased people and processed to remove the cells. It can be glued or sewn onto the skin under local anesthetic, in an out patient setting. DCD has mainly been studied in patients with diabetic foot ulceration and has shown improved healing rates and quality of life.

This study will investigate the use of DCD in addition to compression therapy versus compression therapy alone in patients with chronic venous leg ulceration.

Project Details
Principal Investigator: Mr Baris Ozdemir
Planned End Date: 30/06/2024
Local Ref: 4595

One in every 1000-2000 people in the UK will be diagnosed with advanced cases of Severe Limb Ischemia (SLI) yearly.

As a result of a combination of smoking, diabetes mellitus, high blood pressure, high cholesterol levels, kidney failure and the ageing process, some people develop atherosclerosis (aka ‘hardening’ of the arteries) in their legs. In SLI even minor injuries to the foot can fail to heal, resulting in the development of ulceration, even gangrene.

Unless the blood supply to the leg and foot is improved, many people affected by SLI will lose their limb and/or die within 12 months. As well as causing great suffering, SLI places a large economic burden upon health (NHS) and social care services.

Most SLI patients with disease in the femora-popliteal arteries are treated by endovascular means, which involves opening up the diseased arteries with balloons and sometimes the use of metal tubes called stents. In recent years, a number of “advanced” endovascular technologies - drug eluting stent (DES) and drug coated balloons (DCB) – have become available but the evidence base for using these new technologies is weak and they are much more expensive than the traditional methods.

The purpose of BASIL-3 is to determine which treatment is best at preventing amputation and death, getting the ulcers and gangrene to heal, and relieving pain in people with SLI. The costs of the 3 revascularisation strategies will be studied to see which offers the best value for money for the NHS.

Project Details
Principal Investigator: Peter Mezes
Study Completion: 30/11/2022
Local Ref: 3668

Multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of a `vein bypass first' with a `best endovascular first' revascularisation strategy for severe limb ischemia due to infra-popliteal arterial disease: Bypass vs. Angioplasty in Severe Ischemia of the Leg.

Project Details
Principal Investigator: Mr William Neary
Study Completion: 30/04/2023
Local Ref: 3529

This is an observational clinical study called SAVER. The purpose of SAVER is to collect data on the patients treated with a drug-coated angioplasty balloon called Stellarex™ and assess the balloon’s performance. Patients will be invited to participate in this study if they have leg ischemia (poor blood supply to your leg) generated by the narrowing of a blood vessel.  Angioplasty treatment has been recommended or there is an intention to use the Stellarex balloon to attempt to restore your blood flow in the leg. 

The balloon has been tested, approved and is commercially available in Europe.

The clinical study will be conducted in up to 10000 patients at up to 330 sites throughout the world, including approximately 40 sites in United Kingdom.

There will be no additional testing or assessments required for this study. We are only asking to collect your data from your medical records to continue to assess the treatment by the Stellarex balloon according to the Instructions for Use.

Project Details
Principal Investigator: Peter Mezes
Study Completion: 31/05/2022
Local Ref: 4003

The aim is of the NESIC study is to assess the clinical efficacy and mechanism of NMES compared to best local therapy in the management of IC.

There is a significant global health burden of peripheral arterial disease (PAD), commonly presenting as Intermittent Claudication (IC) or lower limb pain on exertion settling with rest. IC limits exercise tolerance and impairs quality of life.

Management includes cardiovascular risk factor control and supervised exercise therapy (SET), however SET is significantly underutilised and not available in all NHS Trusts, where only exercise advice is provided. Neuromuscular Electrical Stimulation (NMES) may improve the distance walked before symptomatic limitation and improve quality of life.

Project Details
Principal Investigator: Prof Robert Hinchliffe
Study Completion: 30/09/2020
Local Ref: 3903

Abdominal aortic aneurysm (AAA) is a common condition where aorta, the biggest artery, begins to bulge abnormally. Usually this expands over years and can eventually burst, causing fatal internal bleeding. When an emergency life-saving operation is possible, they have high failure rate. A planned AAA repair operation prevents a burst aneurysm.

AAAs vary in complexity. Juxtarenal AAAs are more complex because they are close to the arterial branches to the kidneys. There are different methods of managing such complex aneurysms and doctors are unsure which is better.

The open surgical repair is a durable but serious operation involving slow recovery and higher operative death rates compared to alternative methods, of which Fenestrated Endovascular Aneurysm Repair (FEVAR) is the most established. In some patients with juxtarenal aneurysms, doctors are judiciously using standard endovascular repair (Off-label EVAR), a technique originally intended for use in less complex aneurysms. Endovascular methods cause less of a strain leading to faster recovery and fewer operative deaths, but are less durable requiring further procedures in the years after.

Some patients who are not fit enough to withstand open repair may be able to have endovascular repairs. In some patients no operation may be in their best interest. This study aims to examine how these different treatments compare in terms of clinical benefit and utilisation of NHS resources.

We intend to analyse the outcomes of all patients undergoing juxtarenal aneurysm treatment in England without altering their treatment, during a period of 2 years and collect 5 year follow-up. We plan to examine the routinely performed scans and utilise data that is routinely collected by the NHS. Available data will be analysed to compare the safety and effectiveness of different treatments, and to see if a particular treatment is better suited for particular features so patients can be offered bespoke treatment strategies.

Project Details
Principal Investigator: Dr Paul Bevis
Study Completion: 01/09/2022
Local Ref: 4353

The PERCEIVE study has been developed for adult patients being treated with chronic limb threatening ischaemia (CLTI; inadequate lower limb blood supply  or significant diabetic foot disease (DFD) for whom major lower limb amputation (MLLA) is considered or discussed. Relatives/carers of participating patients will also have the opportunity to get involved.

The study aims to:

• Analyse the communication, consent, risk prediction and decision-making process in relation to MLLA, examined via patient-surgeon consultations and individual patient/HCP interviews.
• Explore and describe how HCPs evaluate risks and outcomes when considering MLLA.
• Explore and describe how risks are communicated and options discussed with patients and relatives/carers, assessing the extent of shared decision-making (SDM) in patient-surgeon consultations.
• Explore and describe patients’ perceptions of decision-making, the communication of risks and benefits of MLLA, expectations for rehabilitation (and whether these are met), and any decisional regret.

This is with the intention of being able to propose (an) intervention(s) to improve shared decision-making and risk perception/communication around MLLA, together with a logic model for the intervention and its future evaluation.

Project Details
Principal Investigator: Chris Twine
Study Completion: 09/09/2022
Local Ref: 4928