IVL L6
Research type
Research Study
Full title
Intravascular Lithotripsy as the primary treatment strategy for calcified Iliac vessels.
IRAS ID
350518
Contact name
Athanasios Saratzis
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
1122, Sponsor Reference Number
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Peripheral arterial disease (PAD) is a common condition in which blood flow to the legs is reduced because arteries become narrowed by fatty deposits and calcium. This can cause pain when walking and, in severe cases, constant pain, ulcers, or gangrene, and may ultimately lead to amputation. PAD is also linked with a high risk of heart attack and stroke. Treating blocked arteries effectively is therefore very important for both limb health and overall survival.
One commonly used treatment is angioplasty, where a balloon is inflated inside the artery to improve blood flow, sometimes followed by insertion of a metal stent. However, heavy calcium within the artery wall makes treatment more difficult and increases the chance that the artery will narrow again. Intravascular lithotripsy (IVL) is a newer technique that uses controlled sound waves delivered through a balloon to crack calcium within the artery, making it easier to open the vessel safely. IVL is already approved for use in the UK and Europe and is part of routine NHS care for selected patients.
Newer IVL devices designed for larger arteries, such as those in the pelvis (iliac arteries) and the lower part of the aorta, are increasingly being used, but there is limited information about their longer-term safety, effectiveness, and costs in everyday clinical practice.
This study is an international, multicentre observational cohort study involving hospitals in the UK, Italy and Switzerland. It will include at least 60 adults with symptomatic PAD who are already planned, as part of their usual care, to receive IVL as the main treatment for calcified iliac or aorto-iliac arteries. The study does not change the treatment patients receive. Instead, it collects information from medical records and routine follow-up, with additional telephone follow-up, over 12 months.
The study will assess how safe and effective IVL is, how often further procedures are needed, rates of complications or hospital readmissions, and basic information on treatment costs. The findings will help patients, clinicians and the NHS understand the benefits, risks and value of IVL in this group of patients, and guide future care.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0033
Date of REC Opinion
11 Feb 2026
REC opinion
Favourable Opinion