NCT07386418 Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
| NCT ID | NCT07386418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Angina (Stable) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-02-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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 on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07386418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Angina (Stable). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07386418 currently recruiting?
Yes, NCT07386418 is actively recruiting participants. Contact the research team at kayla.chiew@imperial.ac.uk for enrollment information.
Where is the NCT07386418 trial being conducted?
This trial is being conducted at Basildon, United Kingdom, Bournemouth, United Kingdom, London, United Kingdom, London, United Kingdom and 3 additional locations.
Who is sponsoring the NCT07386418 clinical trial?
NCT07386418 is sponsored by Imperial College London. The trial plans to enroll 60 participants.