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RECRUITING
NCT07386418
NA

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

Sponsor: Imperial College London

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-02-10

Completion Date

2028-12

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

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.

Locations (6)

Mid and South Essex NHS Foundation Trust

Basildon, United Kingdom

University Hospitals Dorset NHS Foundation Trust

Bournemouth, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom