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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Sponsor: Imperial College London

NCT ID: NCT07386418

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Percutaneous coronary intervention (PCI) (procedure), Measurement of the angina threshold (diagnostic test)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
60
Started
2026-02-10
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for angina (stable)
  • • NA - 60 participants
  • • ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with angina (stable)

Where?

  • • Basildon - Mid and South Essex NHS Foundation Trust
  • • Bournemouth - University Hospitals Dorset NHS Foundation Trust
  • • London - Chelsea and Westminster Hospital NHS Foundation Trust
  • • London - Guy's and St Thomas' NHS Foundation Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

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

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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:

Who cannot take part

  • ✗Age \<18 years
  • ✗Acute coronary syndrome within 3 months
  • ✗Previous coronary artery bypass graft
  • ✗Significant left main stem disease
  • ✗Single lesion amenable to PCI
See the full 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

Where Is This Study? (7 UK sites)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

Recruiting
Site contact (verified)

University Hospitals Dorset NHS Foundation Trust

Bournemouth, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Henry Seligmanh.seligman@nhs.net

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Vasileios Panoulasv.panoulas@imperial.ac.uk

Imperial College Healthcare NHS Trust

London, United Kingdom

Recruiting
Site contact (verified)

Royal Free London NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Rupert Williamsrupertwilliams@nhs.net

How to Get in Touch

Kayla Chiew, MBBS MRCP

Sponsor contact

CONTACT

020 7594 5735 kayla.chiew@imperial.ac.uk

Rasha Al-Lamee, MBBS PhD MRCP

Sponsor contact

CONTACT

020 7594 5735 r.al-lamee13@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-06