Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland

About this trial

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

Qualifiers

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.

It is possible to cross the calcified lesion with a coronary guidewire.

Age ≥ 18 years.

Disqualifiers

Patients with cardiogenic shock.

ST-segment elevation myocardial infarction.

Instent re-stenosis.

Stent thrombosis.

Trial design

Treatments tested in this trial

  • Calcium modification

Treatment groups

500 Participants
are divided into 1 treatment group

Sponsors and collaborators

Royal College of Surgeons, Ireland

Lead sponsor

Cardiovascular Research Institute Dublin

Collaborator