A pragmatic RAndomised controlled trial investigating the use of intraVascular lithotripsy (IVL) in people with peripheral arterial disease (PAD) undergoing Endovascular treatment: The RAVE trial.

Question What is the clinical and cost-effectiveness of using intravascular lithotripsy (IVL) for vessel preparation during endovascular treatment of calcified arteries in people with peripheral arterial disease (PAD)? Background PAD is prevalent in 20% of individuals over 55 in the UK and the main cause of lower limb amputations in the NHS. People with PAD often require revascularisation to re-establish blood flow to the limb. Endovascular (minimally invasive) lower limb revascularisation is the most common arterial procedure in the NHS. Most revascularisations are performed using minimally invasive endovascular procedures. However, arterial calcification, present in up to 80% of PAD patients, complicates these procedures by increasing risks of vessel damage and recurrent arterial occlusions. Intravascular lithotripsy (IVL) is a technology designed to disrupt calcified arterial plaques, potentially improving outcomes. Despite its increasing adoption when treating calcified arteries in people with PAD, no randomised controlled trials (RCTs) have evaluated IVL's clinical/cost-effectiveness vs. standard care. Aims & objectives The primary aim is to assess the clinical and cost-effectiveness of IVL in improving outcomes during and after endovascular revascularisation for PAD. Objectives: 1. Comparing the rate of major adverse events (death, major limb amputation, or arterial re-intervention) between IVL and standard care over a minimum one-year follow-up. 2. Evaluating differences in people’s quality of life between treatment groups. 3. Conducting a full health economic evaluation from an NHS and social care perspective. Methods RAVE is a multicentre, prospective, patient and assessor-blinded RCT involving 306 patients across 24 NHS hospitals. Participants, already selected for endovascular treatment, will be randomised to receive either IVL or standard care for arterial vessel preparation. Inclusion criteria include confirmed arterial calcification and suitability for IVL. Randomisation will occur intra-procedurally after crossing the arterial lesion. The trial includes a six-month internal pilot to assess feasibility based on recruitment and site activation rates. The primary outcome is a composite measure of death, re-intervention, or major amputation within 12-24 months. Secondary outcomes include quality-of-life assessments and health service utilisation data. Timelines • Regulatory approvals & document preparation: 6 months • Pilot phase (site set-up and recruitment): 9 months • Main recruitment phase: 20 months • Follow-up: Minimum 12 months • Data analysis & dissemination: 6 months Total duration: 53 months Impact & dissemination This trial will generate the first randomised evidence on the effectiveness of IVL for PAD patients with calcified arteries. Findings will directly address current clinical uncertainty, potentially reducing mortality, amputations, and re-interventions, and informing updates to international and NICE guidelines. Dissemination plans include a study-specific website, social media updates with infographics, publications in scientific journals, and presentations at conferences. Engagement with national and international professional societies (e.g., VSGBI, BSIR) and guideline committees will further support rapid translation into NHS practice. Educational materials will be co-created with patient and public involvement (PPI) partners to ensure broad accessibility.