CIRSE Initiates ORACLE and RESCUE Studies of Endovascular Interventions for CLTI

September 29, 2026—The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) announced the start of patient enrollment in the ORACLE and RESCUE prospective observational studies of endovascular interventions for patients with chronic limb-threatening ischemia (CLTI). The studies will assess clinical, procedural, and patient-reported outcomes in the treatment of these patients.

CIRSE stated that the two studies are investigating different technologies and treatment strategies but both aim to generate real-world data that can support clinical decision-making and help inform future research in this high-risk patient population.

Participating sites are currently being recruited in Austria, Belgium, Germany, Hungary, Italy, Poland, Spain, Switzerland, and the United Kingdom. Both studies are cochaired by Gerd Grözinger, MD; Marianne Brodmann, MD; Raghu Lakshminarayan, MD; and Stefan Müller-Hülsbeck, MD, advised CIRSE.

According to the society, ORACLE is evaluating the use of orbital atherectomy for lesion preparation and calcium modification in patients with peripheral artery disease (PAD). The single-cohort study is investigating the use of the Stealth 360 peripheral orbital atherectomy system (Abbott) in patients with CLTI and calcified femoropopliteal and infrapopliteal lesions.

RESCUE is evaluating temporary scaffold-based drug delivery in below-the-knee (BTK) revascularization and how this technology may be incorporated into routine clinical practice. The single-cohort study is investigating the use of the Esprit BTK everolimus-eluting resorbable scaffold (Abbott) after adequate vessel preparation in patients with CLTI and infrapopliteal lesions.

Further information is available on the CIRSE ORACLE webpage and the CIRSE RESCUE webpage.

In the CIRSE press release, Dr. Lakshminarayan commented on the ORACLE study and Professor Brodmann discussed RESCUE.

“Calcification is a major challenge, especially in the elderly and frail patients we treat,” noted Dr. Lakshminarayan. “Calcium modification is an area of considerable interest, and the ORACLE study is one of the most exciting studies currently underway in this field.”

He continued, “I’m particularly excited about the study because it will provide real-world insights into how calcium modification occurs in patients with PAD. 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.”

Prof. Brodmann stated, “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.”

She continued, “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.”

Prof. Brodmann concluded, “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.”

The press release advised that ORACLE and RESCUE are scientifically sponsored by CIRSE; designed and managed by Next Research, a contract research organization originating from within CIRSE; and funded by Abbott Vascular International BV through its investigator-sponsored study program.