NCT06678594Recruiting
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)
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 24 Sept 2024
- Primary completion date
- 23 Mar 2026
- Lead sponsor
- Royal College of Surgeons, Ireland
- Diseases
- Coronary artery disease
- NCT number
- NCT06678594
What you commit to
- Study type: Observational
- Planned participants: 500
- From 24 Sept 2024 to the primary completion date, 23 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ST-segment elevation myocardial infarction.
- Stent thrombosis.
Lab values
- 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.
Other
- Patients with cardiogenic shock.
- Instent re-stenosis.
- Coronary artery dissection.
- Chronic total occlusion in a major artery.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Private Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
Related publications
- A Prospective, Multicenter, Open Label Study Investigating the Implementation of a Standardized Algorithm for Coronary CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES): Design and Rationale of the CYCLOPES Trial.Catheter Cardiovasc Interv · 2026 · PMID 41408534
This page is information, not medical advice. Discuss any trial with your doctor.