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Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Percutaneous coronary intervention (PCI) (procedure), Symptom assessment during experimentally induced ischaemia (diagnostic test)
How long the study runs: Study runs about 34 months (dates as stated)
About the drug or intervention: Percutaneous coronary intervention (PCI) — procedure: Coronary artery stenting for stable angina · Symptom assessment during experimentally induced ischaemia — diagnostic test: Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 60
Started: 2024-06-13
Last checked: 2025-06

Plain English Summary

What is this study?

• Testing a new treatment for stable angina
• NA - 60 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with stable angina

Where?

• Basildon - Essex Cardiothoracic Centre
• Bournemouth - Royal Bournemouth Hospital
• Brighton - Royal Sussex County Hospital
• London - Imperial College NHS Trust
• +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Stable AnginaMultivessel Coronary Artery Disease

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

with a positive

What the study is looking for

✓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...
✓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...

Who cannot take part

✗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

See the full 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