The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has announced the start of patient enrolment in ORACLE and RESCUE, two prospective observational studies designed to generate real-world evidence on endovascular interventions for patients with chronic limb-threatening ischaemia (CLTI).
ORACLE and RESCUE will assess clinical, procedural, and patient-reported outcomes in patients with CLTI undergoing endovascular treatment. While the two studies investigate different technologies and treatment strategies, both aim to generate real-world data that can support clinical decision-making and help inform future research in this high-risk patient population.
Patient enrolment for ORACLE and RESCUE started on 31 August 2026. Participating sites are currently being recruited in Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Switzerland, and the UK.
Both studies are co-chaired by Gerd Grözinger (SLK-Kliniken Heilbronn GmbH, Heilbronn, Germany), Marianne Brodmann (Medizinische Universität Graz, Graz, Austria), Raghu Lakshminarayan (Hull University Teaching Hospitals NHS Trust, Hull, UK), and Stefan Müller-Hülsbeck (Malteser Fördeklinikum St. Katharina, Flensburg, Germany).
ORACLE is a prospective observational single-cohort study investigating the use of the Stealth 360 peripheral orbital atherectomy system in patients with CLTI and calcified femoropopliteal and infrapopliteal lesions.
The study evaluates the use of orbital atherectomy for lesion preparation and aims to generate real-world evidence on the use of calcium modification in patients with peripheral arterial disease.
Lakshminarayan highlighted the clinical challenge posed by vascular calcification and the potential of ORACLE to contribute to the evidence base:
“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.’’
RESCUE is a prospective observational single-cohort study investigating the use of the Esprit BTK (Abbott) everolimus-eluting resorbable scaffold following adequate vessel preparation in patients with CLTI and infrapopliteal lesions.
The study aims to generate real-world evidence on temporary scaffold-based drug delivery in below-the-knee revascularisation and to better understand how this technology may be incorporated into routine clinical practice.
Brodmann emphasised the importance of generating clinically relevant evidence in this patient population: “Generating robust real-world evidence on everolimus-eluting resorbable scaffolds is particularly important at this stage. RESCUE has been designed with clinically relevant inclusion criteria and pragmatic exclusion criteria, allowing us to evaluate this technology in a representative patient population. The data generated will help us better understand how resorbable scaffolds can be incorporated into daily clinical practice.
This evidence is especially important for patients with CLTI who often experience severe pain and face a significant risk of amputation, with a profound impact on their quality of life. If this treatment can provide more durable patency and sustained clinical efficacy, it may help more patients preserve their limbs. That would represent a meaningful benefit for patients and provide valuable evidence for the medical community.
RESCUE offers a unique opportunity to advance the evidence base for everolimus-eluting resorbable scaffolds and to translate the resulting data into improved treatment decisions in routine practice.’’
