Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
ORBITA-MOON
2 other identifiers
interventional
60
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedStudy Start
First participant enrolled
June 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 6, 2025
June 1, 2025
2.6 years
April 24, 2024
June 5, 2025
Conditions
Keywords
Outcome Measures
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)
Intra-procedural
Secondary Outcomes (16)
Placebo-controlled intensity score during induced ischaemia at the coronary stenosis
Intra-procedural
Angina symptom type during induced ischaemia at the coronary stenosis
Intra-procedural
Change in angina symptom score
57 days
Angina severity as assessed by Canadian Cardiovascular Society Class
57 days
Angina severity as assessed by MRC dyspnoea scale
57 days
- +11 more secondary outcomes
Study Arms (1)
Patients with stable angina
EXPERIMENTALPatients who: 1. Are symptomatic with angina 2. Have anatomically severe multi-vessel coronary artery disease 3. Have physiological evidence of myocardial ischaemia
Interventions
Coronary artery stenting for stable angina
Transient experimental balloon occlusion across coronary stenosis to determine the symptoms conferred by ischaemia at this stenosis.
Eligibility Criteria
You may qualify if:
- 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 (ICA)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trustcollaborator
- Mid and South Essex NHS Foundation Trustcollaborator
- Imperial College Healthcare NHS Trustcollaborator
- St George's Healthcare NHS Trustcollaborator
- Royal Free Hospital NHS Foundation Trustcollaborator
Study Sites (9)
Essex Cardiothoracic Centre
Basildon, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Imperial College NHS Trust
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
St Georges University Hospital
London, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom
University Hospital Southampton
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasha Al-Lamee, PhD MRCP
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Participants and outcomes assessors will be briefly blinded during the experimental research procedure, during the placebo-controlled balloon inflations when they are asked to report their symptoms. Once the inflations have been completed, all patients will go on to have stents and the blinded part of the protocol will be over.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2024
First Posted
May 6, 2024
Study Start
June 13, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share