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RecruitingNCT06400290ORBITA-MOONUpdated Oct 28, 2026

Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina

An interventional study of Percutaneous coronary intervention (PCI) and Symptom assessment during experimentally induced ischaemia in Stable Angina and Multivessel Coronary Artery Disease, sponsored by Imperial College London. Recruiting at 8 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Updated Oct 28, 2026Enrollment updatedEligibility revised+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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 50 patients with multi-vessel coronary artery disease.

02

Conditions studied

  • Stable Angina
  • Multivessel Coronary Artery Disease

Keywords

  • Angina
  • Multi-vessel coronary artery disease
  • Symptoms
  • Placebo-controlled symptom assessment
03

In context

Angina, Stable

343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.

Browse Angina, Stable studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 28, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
    • CT-FFR
    • invasive metrics of coronary physiology

Exclusion criteria

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
  • to PCI or a drug-eluting stents
  • Contraindication to antiplatelet therapy
  • Contraindication to adenosine
  • Pregnant
  • Inability to consent
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients with stable angina

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

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

Interventions

  • ProcedurePercutaneous coronary intervention (PCI)

    Coronary artery stenting for stable angina

  • Diagnostic testSymptom assessment during experimentally induced ischaemia

    Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.

06

What researchers measure

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

  5. Angina severity as assessed by MRC dyspnoea scale

    MRC dyspnoea score (1-5) (Lower Score = Better Outcome)

    Time frame: 57 days

  6. Physical limitation, angina stability, quality of life, angina frequency, freedom from angina as assessed with the Seattle Angina Questionnaire

    Seattle Angina Questionnaire (0-100), (Higher Score = Better Outcome)

    Time frame: 57 days

  7. Quality of Life assessed with the EQ-5D-5L questionnaire

    EQ-5D-5L Questionnaire (-0.59 to 1), (Higher Score = Better Outcome)

    Time frame: 57 days

  8. Psychological impact of angina as assessed by the PHQ-9 questionnaire

    PHQ-9 Questionnaire (0-27), (Lower Score = Better Outcome)

    Time frame: 57 days

  9. Psychological impact of angina as assessed by the Beck Depression Inventory

    Beck Depression Inventory (0-63), (Lower Score = Better Outcome)

    Time frame: 57 days

  10. Psychological impact of angina as assessed by the Coping Strategies Questionnaire

    Coping Strategies Questionnaire (13-52), (Higher Score = Better Outcome)

    Time frame: 57 days

  11. Psychological impact of angina as assessed by the Pain Catastrophizing Scale

    Pain Catastrophizing Scale (0-52), (Lower Score = Better Outcome)

    Time frame: 57 days

  12. Psychological impact of angina as assessed by the Profile of mood states questionnaire

    Profile of mood states Questionnaire (0-44), (Lower Score = Better Outcome)

    Time frame: 57 days

  13. Psychological impact of angina as assessed by the SCL-90 Questionnaire

    SCL-90 Questionnaire (0-360), (Lower Score = Better Outcome)

    Time frame: 57 days

  14. Need for anti-anginal medication introduction and uptitration

    Has the patient required anti-anginal introduction and/or uptitration. (Score 0-1), (0 = no, 1 = yes)

    Time frame: 57 days

  15. Angina type as assessed by the Rose Chest Pain Questionnaire

    Rose Chest Pain Questionnaire (Score positive or negative), (Positive = pain suggestive of coronary heart disease, negative = pain not suggestive of coronary artery disease)

    Time frame: 57 days

  16. Angina type as assessed by the McGill Pain Questionnaire

    McGill Pain Questionnaire (Score 0-78), (Lower Score = Better Outcome)

    Time frame: 57 days

07

Study locations

7 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site removed
Show 1 removed
  • Nottingham City Hospital · Nottingham, United Kingdom
Oct 28, 2026
Enrollment
60→50
Oct 28, 2026
Eligibility
1 inclusion criterion added
What changed in the criteria
Inclusion criteria
  • AddedCT-FFR
Oct 28, 2026
Sponsor
Collaborators removed: St George's Healthcare NHS Trust·Royal Free Hospital NHS Foundation Trust
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    1 site removed
    Show 1 removed
    • Nottingham City Hospital · Nottingham, United Kingdom
    Enrollment 60→50
    Eligibility 1 inclusion criterion added
    What changed in the criteria
    Inclusion criteria
    • AddedCT-FFR
    Sponsor Collaborators removed: St George's Healthcare NHS Trust·Royal Free Hospital NHS Foundation Trust
    + 3 other changes: verification date, description and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06400290
Collaborators
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
May 6, 2024
Start date
Jun 13, 2024
Primary completion
Jan 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Shayna Chotai, MBBS MRCP
Contact
s.chotai@imperial.ac.uk
02075945735
Rasha Al-Lamee, PhD MRCP
Contact
r.al-lamee13@imperial.ac.uk
02075945735
Rasha Al-Lamee, PhD MRCP
principal investigator · Imperial College London

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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