NCT06678594 Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification
| NCT ID | NCT06678594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Myocardial Ischaemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2026-03-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-09-24 with a primary completion date of 2026-03-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Robert A Byrne
PRINCIPAL INVESTIGATOR
RCSI University of Medicine and Health Sciences
Frequently Asked Questions
Who can join the NCT06678594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myocardial Ischaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678594 currently recruiting?
Yes, NCT06678594 is actively recruiting participants. Contact the research team at robert.byrne@materprivate.ie for enrollment information.
Where is the NCT06678594 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06678594 clinical trial?
NCT06678594 is sponsored by Royal College of Surgeons, Ireland. The principal investigator is Robert A Byrne at RCSI University of Medicine and Health Sciences. The trial plans to enroll 500 participants.