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NCT06400290
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Conditions: Stable Angina, Multivessel Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Imperial College London
Location: Essex Cardiothoracic Centre Basildon
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 50 patients with multi-vessel coronary artery disease.
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
* CT-FFR
* 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
Source: ClinicalTrials.gov (NCT06400290). StuddyBuddy aggregates publicly available trial information.