Angina (Stable)ORBITA-SOLARNCT07386418
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
A study testing Percutaneous coronary intervention (PCI) and Measurement of the angina threshold in people with Angina (Stable) and Coronary Artery Disease(CAD), run by Imperial College London at 7 sites in United Kingdom.
Trial summary
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina (Stable), Coronary Artery Disease(CAD), Ischaemic Heart Disease (IHD)
- What is being tested?
- Percutaneous coronary intervention (PCI) and Measurement of the angina threshold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 10 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
- 2 severe epicardial stenoses in a major coronary artery, defined as:
- ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
- Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
- Evidence of ischaemia on an invasive or non-invasive test, including:
- Physiological test during invasive coronary angiography (ICA)
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- Dobutamine stress echocardiography (DSE)
- Stress perfusion cardiac magnetic resonance (CMR)
- Myocardial perfusion scintigraphy (MPS)
- Fractional flow reserve computed-tomography (FFR-CT)
Who cannot join
- Age <18 years
- Acute coronary syndrome within 3 months
- Previous coronary artery bypass graft
- Significant left main stem disease
- Single lesion amenable to PCI
- Chronic total occlusion of the target artery
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- Moderate to severe valve disease
- LVEF ≤40%, contraindication to PCI or drug-eluting stents
- PCI performed with drug-eluting balloons without stenting
- Contraindication to antiplatelet therapy
- Contraindication to adenosine
- Physical inability to exercise with an ergometer
- Femoral artery access
- Pregnancy
- Inability to consent
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United Kingdom7 sites, 7 recruiting
- Recruiting
Mid and South Essex NHS Foundation Trust
Basildon
John Davies, john.davies32@nhs.net
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Bournemouth
Peter O'Kane, peter.o'kane@uhd.nhs.uk
- Recruiting
Chelsea and Westminster Hospital NHS Foundation Trust
London
Henry Seligman, h.seligman@nhs.net
- Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Vasileios Panoulas, v.panoulas@imperial.ac.uk
- Recruiting
Imperial College Healthcare NHS Trust
London
Rasha Al-Lamee, 02075945735, r.al-lamee13@imperial.ac.uk
- Recruiting
Royal Free London NHS Foundation Trust
London
Niket Patel, niketpatel@nhs.net
- Recruiting
St George's University Hospitals NHS Foundation Trust
London
Rupert Williams, rupertwilliams@nhs.net
About this study
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that corresponds to angina onset.
- Being tested
- Percutaneous coronary intervention (PCI), Measurement of the angina threshold
- Keywords
- Angina, Coronary physiology, Coronary haemodynamics, Placebo-control, Symptoms
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
Clinically indicated PCI for the management of stable angina
Measurement of the angina thresholdDiagnostic test
Following stenting, the order in which to perform the angina threshold assessment at the location of each stent will be randomised. A non-compliant balloon with gradually be inflated over a pressure wire within the deployed stent to re-introduce stenosis. Simultaneously, the participant will exercise on a supine ergometer. At the point when angina is reproduced, the patient will rest and further balloon inflation will stop. Physiological measurements using the pressure wire will be taken with the inflated balloon in situ. This will represent the invasive physiological angina threshold. The balloon will then be deflated and removed. These steps will be repeated at the location of the second stent.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable coronary artery disease | Experimental | 1. Symptoms of stable angina
2. Evidence of ischaemia on an invasive or non-invasive test
3. Two coronary stenoses amenable to percutaneous coronary intervention (PCI) Receives: Procedure: Percutaneous coronary intervention (PCI); Diagnostic Test: Measurement of the angina threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-patient difference in FFR and NHPR angina thresholds
Difference in invasively measured physiological angina thresholds at 2 locations within each participant, stratified by vascular territory and lesion location along a vessel.
Measured: Intra-procedural
Secondary outcomes (6)
Correlation of the angina threshold with other invasive physiological assessments
Including coronary artery disease pattern (focal, diffuse or mixed), presence of microvascular disease (IMR and CFR), extent of collateral flow (CFI), and pre- and post-PCI ischaemia (FFR and RFR)
Measured: Intra-procedural
Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA)
Including proportion of myocardial mass subtended (%), coronary artery territory (LAD, LCx, RCA), and lesion location along a vessel (proximal, mid, distal)
Measured: 14 days
Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA)
Including lesion length (mm), minimum lumen diameter, (mm) percent diameter stenosis (%), and reference vessel diameter (mm)
Measured: 14 days
Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging
Including lesion length (mm), pre-PCI minimum lumen area (mm2), post-PCI minimum stent area (mm2), reference vessel cross-sectional area (mm2), plaque characteristics (lipid, fibrotic, calcific)
Measured: Intra-procedural
Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan
Including myocardial perfusion reserve (MPR), number of segments of infarcted myocardium, and percentage mural infarct depth (%)
Measured: 14 days
Correlation of the angina threshold with baseline symptoms, quality of life and pain perception
Assessed with the ORBITA-app and validated questionnaires (SAQ, EQ5D5L)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina (Stable)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will partake in the same research protocol.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust, Chelsea and Westminster NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386418
- Sponsor's protocol ID
- 199514
- Acronym
- ORBITA-SOLAR
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
- ClinicalTrials.gov ID
- NCT07386418
- Acronym / sponsor ID
- ORBITA-SOLAR / 199514
- Keywords
- Angina, Coronary physiology, Coronary haemodynamics, Placebo-control, Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- St George's University Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust, Chelsea and Westminster NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that corresponds to angina onset.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will partake in the same research protocol.
| Arm | Type | Receives |
|---|---|---|
| Patients with stable coronary artery disease | Experimental | Procedure: Percutaneous coronary intervention (PCI), Diagnostic Test: Measurement of the angina threshold1. Symptoms of stable angina 2. Evidence of ischaemia on an invasive or non-invasive test 3. Two coronary stenoses amenable to percutaneous coronary intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
- 2 severe epicardial stenoses in a major coronary artery, defined as:
- Evidence of ischaemia on an invasive or non-invasive test, including:
Key exclusion criteria (15 listed)
- Age <18 years
- Acute coronary syndrome within 3 months
- Previous coronary artery bypass graft
- Significant left main stem disease
- Single lesion amenable to PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)Clinically indicated PCI for the management of stable angina | Procedure or surgery | Patients with stable coronary artery disease |
| Measurement of the angina thresholdFollowing stenting, the order in which to perform the angina threshold assessment at the location of each stent will be randomised. A non-compliant balloon with gradually be inflated over a pressure wire within the deployed stent to re-introduce stenosis. Simultaneously, the participant will exercise on a supine ergometer. At the point when angina is reproduced, the patient will rest and further balloon inflation will stop. Physiological measurements using the pressure wire will be taken with the inflated balloon in situ. This will represent the invasive physiological angina threshold. The balloon will then be deflated and removed. These steps will be repeated at the location of the second stent. | Diagnostic test | Patients with stable coronary artery disease |
Primary outcome
Within-patient difference in FFR and NHPR angina thresholds
Time frame: Intra-procedural
Difference in invasively measured physiological angina thresholds at 2 locations within each participant, stratified by vascular territory and lesion location along a vessel.
6 secondary outcomes
Correlation of the angina threshold with other invasive physiological assessments
Time frame: Intra-procedural
Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA)
Time frame: 14 days
Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA)
Time frame: 14 days
Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging
Time frame: Intra-procedural
Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan
Time frame: 14 days
Correlation of the angina threshold with baseline symptoms, quality of life and pain perception
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) and Measurement of the angina threshold in people with Angina (Stable) and Coronary Artery Disease(CAD), run by Imperial College London at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Chiew, MBBS MRCP (020 7594 5735, kayla.chiew@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-patient difference in FFR and NHPR angina thresholds (time frame: Intra-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.