Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Launched by IMPERIAL COLLEGE LONDON · May 1, 2024

Keywords

ClinConnect Summary

The ORBITA-MOON trial is a research study designed to learn more about how blockages in the coronary arteries contribute to chest pain, known as angina, in patients who have multiple blocked arteries. It will involve 60 participants who have been diagnosed with multi-vessel coronary artery disease. The study will use a method called balloon occlusion to temporarily block blood flow in specific arteries, allowing researchers to see how each blockage affects the symptoms of angina.

To be eligible for this trial, participants must have significant blockages in two or more coronary arteries and be experiencing angina that may require a procedure called PCI (Percutaneous Coronary Intervention) to help improve blood flow. This trial is open to adults aged 65 to 74, regardless of gender. Participants can expect to undergo tests to confirm their condition and will be closely monitored throughout the study. It's important to note that individuals with certain heart conditions, recent heart attacks, or other specific health issues may not be eligible to join the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligibility for PCI due to angina
• * Anatomical evidence of significant multi-vessel coronary stenosis defined by either:
• • 1. ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)
• • 2. Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA
• * Physiological evidence of ischaemia with a positive test corresponding to the coronary arteries to be stented, on at least one of the following:
• • dobutamine stress echocardiogram
• • cardiac MRI
• • myocardial perfusion study
• • invasive metrics of coronary physiology
• Exclusion Criteria:
• • Recent acute coronary syndrome
• • Previous coronary artery by-pass graft surgery (CABG)
• • Significant left main stem disease
• • Chronic total occlusion in the target artery(s)
• • Moderate to severe valvular disease
• • Moderate to severe left ventricular impairment
• • Contraindication to PCI or a drug-eluting stents
• • Contraindication to antiplatelet therapy
• • Contraindication to adenosine
• • Pregnant
• • Inability to consent