Using a standardized approach to modify calcium in coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate a calcium modification algorithm that guides doctors in treating patients with moderate to severely calcified coronary lesions during percutaneous coronary interventions (PCI). The study will enroll 500 patients across 25 sites in multiple European countries, utilizing high-definition intravascular ultrasound (HD IVUS) to assess lesion characteristics and determine the best treatment approach. By standardizing care through this algorithm, the study seeks to improve decision-making and treatment outcomes for patients with coronary artery disease.

Why it matters

Who can join: the full rules

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 lesion with a coronary guidewire.
4. Age ≥ 18 years.
5. Patient is willing and able to comply with the study procedures and follow-up.

Exclusion Criteria:

1. Patients with cardiogenic shock.
2. ST-segment elevation myocardial infarction.
3. Instent re-stenosis.
4. Stent thrombosis.
5. Coronary artery dissection.
6. Chronic total occlusion in a major artery.
7. 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.

Where it's running

• Mater Private Hospital
  Dublin, Ireland Recruiting

Study contacts

• Principal investigator: Robert A Byrne — RCSI University of Medicine and Health Sciences
• Study coordinator: Robert A Byrne
• Email: robert.byrne@materprivate.ie
• Phone: 00353858802094

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.