Using a standardized approach to modify calcium in coronary arteries

Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)

This study is testing a new method to help doctors treat patients with hardening arteries during heart procedures to see if it leads to better results.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal College of Surgeons, Ireland (other)
• Locations: 1 site (Dublin)
• Trial ID: NCT06678594 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate a calcium modification algorithm that guides doctors in treating patients with moderate to severely calcified coronary lesions during percutaneous coronary interventions (PCI). The study will enroll 500 patients across 25 sites in multiple European countries, utilizing high-definition intravascular ultrasound (HD IVUS) to assess lesion characteristics and determine the best treatment approach. By standardizing care through this algorithm, the study seeks to improve decision-making and treatment outcomes for patients with coronary artery disease.

Who should consider this trial

Good fit: Ideal candidates include adults with documented myocardial ischaemia and moderate to severely calcified coronary lesions suitable for PCI.

Not a fit: Patients experiencing cardiogenic shock or those with lesions not amenable to PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective treatments for patients with calcified coronary artery disease.

How similar studies have performed: While this study employs a novel algorithmic approach, similar studies utilizing intravascular imaging for coronary interventions have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Documented myocardial ischaemia.
2. At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and/or 60MHz HD IVUS, with the presence of significant calcium, ≥70% diameter stenosis by visual estimation (in a reference vessel diameter of ≥2.5mm and ≤4.0mm) and TIMI 3 flow at baseline that is suitable for PCI.

   a. Significant calcium at the target lesion site is defined as either: i. The presence of radiopacities involving both sides of the arterial wall \>10mm and involving the target lesion on angiography.

   or ii. The presence of \>270° arc of superficial calcium on HD intravascular imaging with a length \>5mm or the presence of 360° arc of calcium on HD intravascular imaging. \[1\]
3. It is possible to cross the calcified lesion with a coronary guidewire.
4. Age ≥ 18 years.
5. Patient is willing and able to comply with the study procedures and follow-up.

Exclusion Criteria:

1. Patients with cardiogenic shock.
2. ST-segment elevation myocardial infarction.
3. Instent re-stenosis.
4. Stent thrombosis.
5. Coronary artery dissection.
6. Chronic total occlusion in a major artery.
7. Left ventricular ejection fraction ≤30%. Need for coronary artery bypass graft surgery.

9\. Documented allergy to everolimus or to any stent material 10. Any contraindication for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for at least 3 months (except for patients on oral anticoagulation). 11. For female, pregnancy, breastfeeding or intend to become pregnant within 1 year 12. Life expectancy \<1 year. 13. Participation in another study with an investigational product. 14. Inability to provide informed consent.

Where this trial is running

Dublin

• Mater Private Hospital — Dublin, Ireland (RECRUITING)

Study contacts

• Principal investigator: Robert A Byrne — RCSI University of Medicine and Health Sciences
• Study coordinator: Robert A Byrne

Conditions: Myocardial Ischaemia, Severely Calcified Coronary Stenoses, Coronary Calcification, calcium modification, coronary calcification, plaque modification, IVUS, Intravascular Ultrasound