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Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
RECRUITINGN/ASponsored by Imperial College London
Actively Recruiting
PhaseN/A
SponsorImperial College London
Started2024-06-13
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06400290
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
Heart DiseaseMultivessel Coronary Artery DiseaseStable Angina
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Actively Recruiting
PhaseN/A
SponsorImperial College London
Started2024-06-13
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06400290