CYCLOPES

• Research type

  Research Study

• Full title

  Implementation of a Standardized Algorithm for CoronarY CaLcificatiOnwith PlaquE Modification using UltraSound Guidance to ImproveProcedural and Clinical Outcomes (CYCLOPES)

• IRAS ID

  352473

• Contact name

  Peter O Kane

• Contact email

  Peter.o'kane@uhd.nhs.uk

• Sponsor organisation

  Royal College of Surgeons in Ireland RCSI

• Clinicaltrials.gov Identifier

  NCT06678594

• Duration of Study in the UK

  2 years, 6 months, 31 days

• Research summary

  Up to one third of patients undergoing coronary angiography have moderate to severe calcium build-up in their heart arteries. As the population ages, the number of patients with calcified coronary lesions requiring complex percutaneous coronary intervention (PCI) is expected to increase. Calcified arteries make procedures more difficult, often resulting in longer treatment times and poorer outcomes.
  To improve these outcomes, it is important to prepare the artery by modifying the calcium before placing a stent. Several approved devices are available on the market for this purpose, including high-pressure balloons, cutting balloons, rotational atherectomy devices, and intravascular lithotripsy (IVL). Choosing the right tool, however, can be challenging.

  The CYCLOPES study is evaluating a step-by-step calcium modification algorithm that uses intravascular ultrasound (IVUS) imaging to guide treatment. IVUS allows doctors to see inside the artery and assess how the calcium is distributed. Based on these images, the most appropriate method to treat the calcium is selected using the CYCLOPES protocol. The study aims to assess whether using this imaging-based algorithm can improve the safety, effectiveness, and long-term outcomes of stent procedures in patients with complex, calcified coronary disease.

  This prospective, multicentre, open-label study will include 500 patients across 25 hospitals in seven European countries. Around 80 patients will be recruited in the United Kingdom.
  
  Patients will receive standard PCI treatment after calcium modification guided by the algorithm. All medical devices used (IVUS, coronary stents, calcium modification devices) are CE-certified, used according to their instructions for use. Each patient will undergo three IVUS scans: before calcium modification, after modification, and after stent placement. The procedure follows standard clinical practice, and patients will not undergo any additional or experimental interventions.

  Patients will be followed for 12 months with check-ins at discharge, 30 days, and one year after the procedure—either by phone or clinic visits.
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0672

• Date of REC Opinion

  10 Nov 2025

• REC opinion

  Further Information Favourable Opinion