Vascular procedure

Vascular Completed Research

The Vascular Research team conducts research that aims to improve the care of men and women using vascular services department at NBT. This includes arterial surgery, diabetic foot care, leg ulcers, varicose veins, and other vascular diseases.

We have had a successful research team in place for several years delivering complex interventional and observational studies.

The team collaborates widely with other disciplines and professions to develop ground-breaking research and care, for our patients and throughout the NHS.

Please speak to the person treating you to see if there is a research study that may be able to help you.

Completed Studies:

BASIL-3

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

BASIL-2

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

SAVER - Prospective, international, non-interventional study with the aim to assess the treatment by the Stellarex Balloon according to the instructions For Use

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

Critical Limb Ischemia-349/0003-Pluristem

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for Revascularization (PACE Study).

Following a screening period of up to 5 weeks, subjects will be randomized using a 2:1 ratio to receive PLX-PAD 300×106 cells or placebo, respectively. Subjects will receive the assigned treatment twice, 60 days apart. All subjects will be followed-up until the End of Study or until completing 36 months of follow-up - the earlier of the two (defined for each subject as the “Termination Visit”). Hence, the study participation for a particular subject will range between 12 to 36 months. Study visits will be conducted every month up to Month 6, then every 3 months until Month 12, and for subjects followed more than 12 months, every 4 months until the subject’s Termination Visit (as defined above).

Follow-up visits will include clinical assessments of the limb ischemia via ischemic lesions size and ischemic pain, as well as subjects’ quality of life (QoL) (via health-related and disease-related questionnaires), and physiologic parameters (ABI, TBI, TcPO2 and/or other non-invasive measurement of perfusion [sub-study]). In addition, safety assessments including adverse events (AEs), physical examination, vital signs and laboratory tests will be monitored during the study. Additional laboratory tests such as cytokine levels, T-cell activation, messenger ribonucleic acid (mRNA), circulating endothelial cells (CEC) and endothelial progenitor cells (EPC) and diabetes tests will be performed for research purposes in subsets of study subjects.

Subjects who underwent a major amputation should be encouraged to continue study follow-up visits as scheduled for 1 year following the procedure or end of study – the earlier of the two. All subjects will receive PLX-PAD/placebo in addition to best standard of care according to local medical practices, including control of cardiovascular risk factors, statins, anti-platelet drugs (unless on chronic anticoagulation therapy, or if contra-indicated), wound care management, and analgesics, as appropriate.

Project Details
Principal Investigator: Prof Robert Hinchliffe
Study Completion: 01/05/2020
Local Ref: 3903

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About Research & Innovation

NBT Researcher

Find out more about our research and how we're working to improve patient care.

Contact Research & Innovation

Research & Innovation
North Bristol NHS Trust
Floor 3, Learning & Research Centre
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB

Telephone: 0117 4149330
Email: research@nbt.nhs.uk