SHOCC study
Research type
Research Study
Full title
SHOCkwave lithotripsy for Calcified plaques in patients with peripheral arterial disease: a pragmatic registry with in-depth automated plaque analysis – the SHOCC study.
IRAS ID
299307
Contact name
Matthew Brown
Contact email
Sponsor organisation
The University of Leicester
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
Research Summary
Peripheral arterial disease (PAD) is a condition where the arteries carrying blood to the legs become narrowed or blocked. It affects one in five people aged over 55. Many patients with PAD need treatment to re-open their arteries. This will improve blood flow to their legs and prevent amputation. This treatment usually involves keyhole surgery, called “endovascular” treatment. The most common form of endovascular treatment for patients with PAD involves stretching an artery open with a balloon. Arteries which have lots of calcium deposits, which is often found in PAD, cannot be stretched open using standard balloons. To address this, a new form of balloon has been developed. This is called intravascular lithotripsy. This balloon emits ultrasounds in order to break the calcium deposits of the artery. Doctors can then stretch the artery open more efficiently. This treatment is now available in the NHS.The aim of this study is to collect information relating to the care of patients with PAD who undergo tintravascular lithotripsy in the NHS. We will collect information about the procedures that these patients undergo in 4 NHS hospitals and then follow up these patients after 6 months to assess what happened to their legs. We will also ask 20 patients to take part in a smaller sub-study, where we will check the change in the calcium deposits of their arteries immediately after treatment with intravascular lithotripsy by doing an additional scan. Finally, we will ask 10 doctors to fill in a survey about intravascular lithotripsy.
This study will help us understand whether this treatment is good at treating arteries with lots of calcium deposits and does indeed prevent leg amputations 6 months after treatment. It will also provide us with valuable information necessary to plan a future big national study assessing this new therapy across the NHS.
Summary of Results
Why we undertook the work: Blockages and narrowing in arteries supplying blood to the legs are common. This condition is called peripheral arterial disease or PAD in short. Often, these narrowings and blockages have lots of calcium. A new device called lithotripsy has been developed recently to allow healthcare professionals to open up calcified artery blockages. This work aimed to look at whether lithotripsy used for PAD in the NHS is safe and leads to acceptable results.
What we did: A national research study was done, across eight NHS hospitals. A total of 91 people took part in this research, who had PAD and needed lithotripsy treatment.
What we found: Lithotripsy is safe to use as 100% of the procedures for the participants in the study were successfully completed. Complications were not more common compared to other technologies used for such calcified arteries. Also, with imaging before and after lithotripsy treatment, we found that lithotripsy breaks down artery calcium.
What this means: Lithotripsy can be used safely in the NHS. Future work should include a randomised trial, where people with PAD are treated with lithotripsy and compared to other modes of treatment.REC name
Wales REC 4
REC reference
21/WA/0270
Date of REC Opinion
20 Sep 2021
REC opinion
Further Information Favourable Opinion