Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modifica
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 p
| Condition(s) | Myocardial Ischaemia, Severely Calcified Coronary Stenoses, Coronary Calcification |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 s |
| Who can participate | 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 lesi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Royal College of Surgeons, Ireland |
| Locations | Dublin, Ireland |
| Start date | 2024-09-24 |
| NCT ID | NCT06678594 |
| Official listing | https://clinicaltrials.gov/study/NCT06678594 |