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.

Eligibility criteria

Qualifiers

Eligibility for PCI due to angina or angina-equivalent symptoms on exertion

≥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

Physiological test during invasive coronary angiography (ICA)

Disqualifiers

Age <18 years

Acute coronary syndrome within 3 months

Previous coronary artery bypass graft

Significant left main stem disease

Trial design

Treatments tested in this trial

  • Percutaneous coronary intervention (PCI)
  • Measurement of the angina threshold

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

7
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

Sponsors and collaborators

Imperial College London

Lead sponsor

St George's University Hospitals NHS Foundation Trust

Collaborator

Royal Free Hospital NHS Foundation Trust

Collaborator

University Hospitals Dorset NHS Foundation Trust

Collaborator

Mid and South Essex NHS Foundation Trust

Collaborator

Imperial College Healthcare NHS Trust

Collaborator

Chelsea and Westminster NHS Foundation Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborator