Actively Recruiting
Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification
Led by Royal College of Surgeons, Ireland · Updated on 2024-11-07
500
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Royal College of Surgeons, Ireland
Lead Sponsor
C
Cardiovascular Research Institute Dublin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented myocardial ischaemia.
- At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and/or 60MHz HD IVUS with 50% diameter stenosis, reference vessel diameter 2.5mm and 4.0mm, and TIMI 3 flow at baseline suitable for PCI.
- Significant calcium defined as either radiopacities >10mm involving both sides of the arterial wall on angiography or >2706 arc of superficial calcium >5mm length or 3606 arc of calcium on HD intravascular imaging.
- Ability to cross the calcified lesion with a coronary guidewire.
- Age 18 years or older.
- Willingness and ability to comply with study procedures and follow-up.
You will not qualify if you...
- Cardiogenic shock.
- ST-segment elevation myocardial infarction.
- Instent re-stenosis.
- Stent thrombosis.
- Coronary artery dissection.
- Chronic total occlusion in a major artery.
- Left ventricular ejection fraction 30%.
- Need for coronary artery bypass graft surgery.
- Allergy to everolimus or any stent material.
- Contraindication to dual antiplatelet therapy with aspirin and P2Y12 inhibitor for at least 3 months (except oral anticoagulation).
- Pregnancy, breastfeeding, or intention to become pregnant within 1 year.
- Life expectancy less than 1 year.
- Participation in another investigational study.
- Inability to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mater Private Hospital
Dublin, Ireland
Actively Recruiting
Research Team
R
Robert A Byrne
CONTACT
A
Amy Carswell
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here