RecruitingNot ApplicableNCT07386418

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Sponsor

Imperial College London

Enrollment

60 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease (CAD)Angina, Stable ischaemic heart disease (IHD)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Measurement of the angina threshold and a procedure called Percutaneous coronary intervention (PCI) for people with angina, stable, coronary artery disease (cad), and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPercutaneous coronary intervention (PCI)

Clinically indicated PCI for the management of stable angina

DIAGNOSTIC_TESTMeasurement 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.