RecruitingNCT06678594

Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification

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

Sponsor

Royal College of Surgeons, Ireland

Enrollment

500 participants

Start Date

Sep 24, 2024

Study Type

OBSERVATIONAL

Conditions

Myocardial ischaemia Coronary Calcification Severely Calcified Coronary Stenoses

Summary

In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Algorithms are useful because they help doctors decide on the best treatment approach based on the patient's individual circumstances and the best medical evidence available. The algorithm that is being used in this study is called a calcium modification algorithm and it will guide doctors when deciding on the best way to modify or break up the calcium in coronary arteries. In this study, we aim to prove that the calcium modification algorithm, described above, safely and effectively guides doctors on the best way to modify calcium in patients' coronary arteries. By doing so, it will help doctors in making decisions about patients' treatment during their procedure. It will also help standardise care for patients, so patients receive the same treatment no matter what hospital they are in or what doctor is treating them.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Documented myocardial ischaemia.
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. \[1\]
It is possible to cross the calcified lesion with a coronary guidewire.
Age ≥ 18 years.
Patient is willing and able to comply with the study procedures and follow-up.

Exclusion Criteria8

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

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Interventions

PROCEDURECalcium modification

Patients will undergo one or more of the following procedures, subject to the algorithm: Angioplasty Balloon Cutting Balloon Rotational Atherectomy Intravascular Lithotripsy