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Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

ConditionsStable AnginaMultivessel Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eligibility for PCI due to angina

≥70% stenosis in two or more coronary arteries of ≥2.5mm visual diameter stenosis, on invasive coronary angiography (ICA)

Severe stenosis in ≥2 coronary arteries of ≥ 2.5mm visual diameter stenosis, on CTCA

dobutamine stress echocardiogram

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Percutaneous coronary intervention (PCI)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with stable anginaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Placebo-controlled similarity score during induced ischaemia at the coronary stenosis

The patient scores the similarity of the angina experienced during the experimental balloon inflation procedure against the angina experienced before the procedure between 0-10 (Higher Score = Most similar)

Time frame
Intra-procedural

Secondary outcomes

1

Placebo-controlled intensity score during induced ischaemia at the coronary stenosis

The patient scores the severity of the angina experienced during the experimental balloon inflation procedure between 0-10 (Higher Score = More severe)

Time frame
Intra-procedural
2

Angina symptom type during induced ischaemia at the coronary stenosis

The patient will list all symptoms experienced during the experimental balloon inflation procedure.

Time frame
Intra-procedural
3

Change in angina symptom score

Fractional Change in Angina Frequency (0-1) (Lower Score = Better Outcome)

Time frame
57 days
4

Angina severity as assessed by Canadian Cardiovascular Society Class

Canadian Cardiovascular Society Class (0-IV) (Lower Score = Better Outcome)

Time frame
57 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Collaborator

Mid and South Essex NHS Foundation Trust

Collaborator

Imperial College Healthcare NHS Trust

Collaborator

St George's Healthcare NHS Trust

Collaborator

Royal Free Hospital NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
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