Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

Last updated: June 5, 2025
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Coronary Artery Disease

Angina

Treatment

Percutaneous coronary intervention (PCI)

Symptom assessment during experimentally induced ischaemia

Clinical Study ID

NCT06400290
21HH7372
NIHR302493
  • Ages > 18
  • All Genders

Study 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

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 diameterstenosis, on invasive coronary angiography (ICA)

  2. Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, onCTCA

  • Physiological evidence of ischaemia with a positive test corresponding to thecoronary 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

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Percutaneous coronary intervention (PCI)
Phase:
Study Start date:
June 13, 2024
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Essex Cardiothoracic Centre

    Basildon,
    United Kingdom

    Active - Recruiting

  • Royal Bournemouth Hospital

    Bournemouth,
    United Kingdom

    Active - Recruiting

  • Royal Sussex County Hospital

    Brighton, BN2 5BE
    United Kingdom

    Active - Recruiting

  • Imperial College NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free London NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • St Georges University Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB
    United Kingdom

    Active - Recruiting

  • Portsmouth Hospitals University NHS Trust

    Portsmouth,
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

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