An interventional study of Percutaneous coronary intervention (PCI) and Measurement of the angina threshold in Angina (Stable), Coronary Artery Disease(CAD) and Ischaemic Heart Disease (IHD), sponsored by Imperial College London. Recruiting at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 230 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →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.
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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.
2 severe epicardial stenoses in a major coronary artery, defined as:
Evidence of ischaemia on an invasive or non-invasive test, including:
Exclusion Criteria:
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Percutaneous coronary intervention (PCI) · Diagnostic Test: Measurement of the angina threshold
Clinically indicated PCI for the management of stable angina
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.
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.
Time frame: Intra-procedural
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 (%)
Time frame: 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)
Time frame: 14 days
Plan to share: No
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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 ↗
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