NCT06400290 Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
| NCT ID | NCT06400290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Stable Angina |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-13 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Rasha Al-Lamee, PhD MRCP
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06400290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stable Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06400290 currently recruiting?
Yes, NCT06400290 is actively recruiting participants. Contact the research team at s.chotai@imperial.ac.uk for enrollment information.
Where is the NCT06400290 trial being conducted?
This trial is being conducted at Basildon, United Kingdom, Bournemouth, United Kingdom, Brighton, United Kingdom, London, United Kingdom and 5 additional locations.
Who is sponsoring the NCT06400290 clinical trial?
NCT06400290 is sponsored by Imperial College London. The principal investigator is Rasha Al-Lamee, PhD MRCP at Imperial College London. The trial plans to enroll 60 participants.