Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina (ORBITA-MOON)

Imperial College London

Status: Enrolling

Conditions: Multivessel Coronary Artery Disease; Stable Angina

Treatments: Procedure: Percutaneous coronary intervention (PCI); Diagnostic Test: Symptom assessment during experimentally induced ischaemia

Study type: Interventional

Funder types: Other

Identifiers

NCT06400290

21HH7372

NIHR302493 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients with stable angina

Experimental group

Description:

Patients who: 1. Are symptomatic with angina 2. Have anatomically severe multi-vessel coronary artery disease 3. Have physiological evidence of myocardial ischaemia

Treatment:

Diagnostic Test: Symptom assessment during experimentally induced ischaemia

Procedure: Percutaneous coronary intervention (PCI)