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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Sponsor: Imperial College London • ClinicalTrials.gov ID: NCT07386418

Registry updated: 2026-10-19

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Description

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.

Interventions

Percutaneous coronary intervention (PCI) (Procedure)
Clinically indicated PCI for the management of stable angina
Measurement of the angina threshold (Diagnostic 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.

Eligibility criteria

Inclusion Criteria: 1. Eligibility for PCI due to angina or angina-equivalent symptoms on exertion 2. 2 severe epicardial stenoses in a major coronary artery, defined as: 1. ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA) 2. Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA 3. Evidence of ischaemia on an invasive or non-invasive test, including: 1. Physiological test during invasive coronary angiography (ICA) 2. Dobutamine stress echocardiography (DSE) 3. Stress perfusion cardiac magnetic resonance (CMR) 4. Myocardial perfusion scintigraphy (MPS) 5. Fractional flow reserve computed-tomography (FFR-CT) Exclusion Criteria: 1. Age \<18 years 2. Acute coronary syndrome within 3 months 3. Previous coronary artery bypass graft 4. Significant left main stem disease 5. Single lesion amenable to PCI 6. Chronic total occlusion of the target artery 7. Moderate to severe valve disease 8. LVEF ≤40%, contraindication to PCI or drug-eluting stents 9. PCI performed with drug-eluting balloons without stenting 10. Contraindication to antiplatelet therapy 11. Contraindication to adenosine 12. Physical inability to exercise with an ergometer 13. Femoral artery access 14. Pregnancy 15. Inability to consent

Conditions

Angina (Stable) Coronary Artery Disease(CAD) Ischaemic Heart Disease (IHD)

Locations

Mid and South Essex NHS Foundation Trust — Basildon, United Kingdom
University Hospitals Dorset NHS Foundation Trust — Bournemouth, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust — London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
Imperial College Healthcare NHS Trust — London, United Kingdom
Royal Free London NHS Foundation Trust — London, United Kingdom
St George's University Hospitals NHS Foundation Trust — London, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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