NCT07386418

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angina (Stable)
• Ischaemic Heart Desease
• Coronary Artery Disease(CAD)

Interventions

Type	Name	Description
PROCEDURE	Percutaneous coronary intervention (PCI)	Clinically indicated PCI for the management of stable angina
DIAGNOSTIC_TEST	Measurement of the angina threshold	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.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-02-04
• Last updated: 2026-02-18

Locations

6 sites across 1 country: United Kingdom