Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Study acronym: ORBITA-SOLAR
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 25 words
    • Site details revised at 4 of 7 sites
    • Collaborators: details revised at 2 of 8 entries
  2. Study sites: 6 to 7
    • Collaborators: 6 to 8
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2026 to Feb 10, 2026
    • Site details revised at 6 of 6 sites
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07386418
Lead Sponsor Imperial College London
Collaborators: St George's University Hospitals NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust, Chelsea and Westminster NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust
Conditions
(from sponsor)		 Angina (Stable), Coronary Artery Disease(CAD), Ischaemic Heart Disease (IHD)
Related terms Angina Pectoris, Angina, Stable, Coronary Artery Disease
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov