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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with severe coronary calcification requiring calcium modification and percutaneous coronary revascularization
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Calcium modification
Procedure/SurgeryPatients will undergo one or more of the following procedures, subject to the algorithm: Angioplasty Balloon Cutting Balloon Rotational Atherectomy Intravascular Lithotripsy
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patient treatment will follow a standardised algorithm for calcium modification1 intervention
Trial outcomes
Primary outcomes
1
Minimum stent area (MSA)
Minimum stent area (MSA) at the site of maximum calcification measured at the end of the index procedure
Time frame
End of Index Procedure2
Target lesion failure (TLF)
Target lesion failure (TLF) (cardiovascular death, non-fatal myocardial infarction (MI) related to the target vessel, unplanned ischemia-driven target lesion revascularization) at 1 year
Time frame
At Year 1Secondary outcomes
1
Individual components of TLF at 1 month and 1 year
Individual components of TLF at 1 month and 1 year
Time frame
At 1 month and 1 year2
Minimum stent area (MSA) at the end of the index procedure
Minimum stent area (MSA) at the end of the index procedure
Time frame
At end of index procedure3
Strategy Success
Strategy success defined as: 1. Successful stent delivery 2. ≥ 80% stent expansion 3. Complete stent apposition 4. No edge dissection 5. Full lesion coverage with \<50% plaque burden at proximal and distal references 6. TIMI 3 flow
Time frame
At end of index procedure4
Target vessel revascularization (TVR)
Target vessel revascularization (TVR)
Time frame
At Year 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal College of Surgeons, Ireland
Lead sponsor
Cardiovascular Research Institute Dublin
Collaborator
Source ClinicalTrials.gov