September 11, 2025
CIRSE has taken another significant step in strengthening the evidence base for interventional radiology.
CIRSE launches three landmark studies to advance interventional radiology data
CIRSE has launched three new independent, European, real-world observational studies: ORACLE, RESCUE, and BRIGHT. These initiatives will not only broaden the data available for clinical decision-making but also provide important insights to support access and reimbursement for innovative therapies.
ORACLE: Expanding evidence for orbital atherectomy in CLTI
The ORACLE study will investigate the use of orbital atherectomy with the Stealth 360™ system for vessel preparation in the treatment of femoropopliteal or infrapopliteal calcified lesions in patients with chronic limb-threatening ischaemia (CLTI). Orbital atherectomy removes calcium build-up in arteries, thereby leading to improved clinical outcomes when balloon angioplasty, stents or other adjunct therapies are applied to the vessels. Conducted independently by CIRSE with financial support from Abbott Vascular, the study aims to provide robust real-world data on safety and effectiveness outcomes for this challenging patient population.
By systematically collecting multicentre data, ORACLE will help to clarify the role of orbital atherectomy in improving clinical outcomes of endovascular interventions for CLTI patients across Europe.
RESCUE: Esprit™ BTK Scaffolds in treating infrapopliteal lesions
The RESCUE study will focus on the use of Esprit™ BTK Everolimus Eluting Resorbable Scaffold System in infrapopliteal lesions in CLTI patients. The scaffolds deliver antiproliferative agents directly to the vessel wall to reduce neointimal thickening and ultimately restenosis. Additional advantages of the scaffolds include their temporary structural support and resorption capabilities over time, minimising long-term risks stemming from permanent stents. Also supported by Abbott Vascular, RESCUE will provide independent evidence on the performance and durability of this device in a real-world setting.
With CLTI patients often facing limited treatment options and high risks of amputation, RESCUE will be a key resource for understanding how novel endovascular technologies can improve limb salvage and patient quality of life.
BRIGHT: Advancing care in haemorrhoidal disease
Through BRIGHT, CIRSE expands its research efforts into a new area — benign disease. This prospective, multicentre observational study will recruit up to 250 patients with bleeding grade II–III haemorrhoids treated with haemorrhoid artery embolisation (HAE) using coil embolisation only. This minimally invasive approach offers several benefits compared to surgical options, including shorter recovery time, reduced surgical trauma, and safer alternative for high-risk patients who are unfit for general anaesthesia or surgery.
The study will primarily assess bleeding reduction using the French Bleeding Score at 12 months with secondary outcomes including pain, recurrence, continence, symptom control, recovery time, and cost-effectiveness. Funded by Medtronic and Cook Medical, BRIGHT will be sponsored by CIRSE and managed by Next Research with scientific guidance from an international steering committee.
By systematically evaluating this minimally invasive approach, BRIGHT has the potential to redefine treatment pathways and provide patients with an alternative to more invasive surgical options.
Strengthening IR’s Evidence Base
ORACLE, RESCUE, and BRIGHT represent CIRSE’s ongoing commitment to generating independent, high-quality data to support interventional radiology. Each study reflects a strong collaboration between CIRSE, industry partners, and leading investigators, ensuring that the studies are conducted with scientific independence and clinical relevance.
Data derived from real-world evidence, including patient registries and single-arm observational studies, is increasingly recognized as a powerful and valuable complement to randomised controlled trials. Additionally, such evidence captures diverse patient populations and clinical contexts in an expediated and cost-efficient manner, compared to randomised controlled trials (Kaufmann and Pereira, 2025, Real-world evidence: better than nothing or the future? A perspective on clinical evidence generation in Interventional Oncology, CVIR (in press)).
As these studies progress, CIRSE members will play a vital role in shaping the future of patient care by contributing to data collection, clinical insights, and results dissemination. Their involvement will ensure that the study findings are translated into real-world practices, thereby improving patient outcomes, strengthening the IR evidence base, and driving innovation.