September 28, 2026
The CIRSE-sponsored ORACLE study – ORbital Atherectomy for lesion preparation in patients with Chronic Limb-threatening ischaemia – has begun enrolling patients, marking the official start of data collection.
Patient enrolment has begun for the ORACLE study
ORACLE Coordinating Investigators at the CIRSE 2025 Annual Congress in Barcelona. Photo edited with AI
Study summary
ORACLE is a Europe-wide, prospective, observational single-cohort study designed to evaluate the effectiveness of orbital atherectomy (OA) in patients with critical limb-threatening ischemia (CLTI). The study aims to generate real-world data on the use of this vessel preparation technique for the treatment of calcified femoropopliteal or infrapopliteal lesions.
The study’s primary objective is to assess how effectively OA, along with any planned adjunctive intervention, restores normal vessel lumen immediately after the procedure. The study will also examine long-term outcomes, including amputation-free survival, freedom from target lesion revascularisation, clinical response, wound healing, overall survival, and health-related quality of life.
ORACLE aims to recruit 250 participants over a three-year enrolment period. Follow-up data will continue to be collected for an additional two years beyond the enrolment phase. Participating sites are being recruited in Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Switzerland, and the United Kingdom.
Study management
Next Research, CIRSE’s research organisation, serves as the master administrator of ORACLE and is responsible for the study’s day-to-day management. ORACLE is funded by Abbott Vascular International through its Investigator Sponsored Study Program.
Study leadership
The following experts serve as the Co-coordinating Investigators and Co-chairpersons for the Steering Committee:
| Gerd Grözinger | SLK-Kliniken Heilbronn GmbH, Heilbronn, Germany |
| Marianne Brodmann | Medizinische Universität Graz, Graz, Austria |
| Raghuram Lakshminarayan | Hull University Teaching Hospitals NHS Trust, Hull, UK |
| Stefan Müller-Hülsbeck | Malteser Fördeklinikum St. Katharina, Flensburg, Germany |
Investigator perspective: why ORACLE matters
Raghu Lakshminarayan, ORACLE Coordinating Investigator, shared his thoughts on what makes this study unique and highlighted its potential contribution to clinical practice:
“Calcification is a major challenge, especially in the elderly and frail patients we treat. Calcium modification is an area of considerable interest, and the ORACLE study is one of the most exciting studies currently underway in this field. I’m particularly excited about the study because it will provide real-world insights into how calcium modification occurs in patients with peripheral arterial disease.
I would encourage physicians to consider orbital atherectomy and keep the ΟRACLE study in mind when treating calcified lesions, so that we can obtain the data needed to better inform clinical practice.”