Orbital atherectomy for lesion preparation in patients with chronic limb-threatening ischemia

Research summary

Chronic limb-threatening ischaemia (CLTI) is an advanced form of poor blood circulation in the legs which can lead to severe pain, wounds that do not heal, and amputation. Most patients with CLTI have severe calcium build-up in their blood vessels, which stiffens the vessel wall and makes it difficult to open narrowed arteries using standard endovascular treatments such as balloons or stents. Orbital atherectomy (OA) is a vessel preparation technique that uses sanding and pulsatile mechanical forces to modify calcified plaque before other endovascular treatments are performed. By improving vessel compliance, OA facilitates vessel opening and help improve blood flow. Although several studies have reported promising results with OA, existing evidence mainly comes from small retrospective studies with limited long-term follow-up and underrepresentation of patients with CLTI. ORACLE is a prospective multicentre observational study designed to generate evidence on the use of OA for CLTI patients in real-life clinical practice. The primary objective of the study is to evaluate how effectively OA facilitates the opening of narrowed vessels. A key secondary objective is to assess how well it helps prevent major amputations. The study will also evaluate wound healing, procedural safety, survival, and patient quality of life. ORACLE follows routine clinical care and does not require any additional study-specific hospital visits or burdensome procedures. Study data will be collected from medical records and from a voluntary patient questionnaire on health-related quality of life. Follow-up information may be collected by telephone if no routine hospital visit is planned at the relevant time point. Approximately 250 patients across multiple centres in Europe will be included. Overall, ORACLE aims to improve our understanding of the role of OA in the treatment of heavily calcified arterial disease in patients with CLTI and may help inform clinical decision-making and treatment strategies for this high-risk population.

Principal Investigator

Dr Raman Uberoi

Contact us

Email: Avianna.laws@ouh.nhs.uk

IRAS number

372024