Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Imperial College London
60 participants
Jun 13, 2024
INTERVENTIONAL
Conditions
Summary
ORBITA-MOON is a double-blinded, placebo-controlled experimental study that aims to understand how the different coronary artery stenoses contribute to overall clinical angina in patients with multi-vessel coronary artery disease. This study will investigate the symptoms conferred by each stenosis, induced by experimental ischaemia, for 60 patients with multi-vessel coronary artery disease.
Eligibility
Inclusion Criteria9
- Eligibility for PCI due to angina
- Anatomical evidence of significant multi-vessel coronary stenosis defined by either:
- ≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)
- 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 Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Coronary artery stenting for stable angina
Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06400290