Status:
COMPLETED
Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Echopoint Medical Ltd
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this investigation is to see if the newly developed "iKOs™ microcatheter" can safely and accurately measure flow and pressure within the heart arteries of 10 patients undergoing angiogr...
Detailed Description
After being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. Those who ar...
Eligibility Criteria
Inclusion
- Able and willing to give informed consent
- \>18 years old
- Have a clinical diagnosis of coronary artery disease
- Undergoing further assessment of a coronary artery with a pressure wire study
Exclusion
- General
- Previous coronary artery bypass grafting.
- Non/ST-elevation myocardial infarction as indication for angiography.
- Ongoing evidence of ischaemia at rest.
- Severe renal impairment (GFR \<25).
- Severe anaemia (Hb \<10).
- Heparin allergy.
- Atrial fibrillation.
- Contraindication to adenosine.
- Pregnant or lactating; or female of childbearing potential.
- Participation in other interventional studies.
- Additional exclusion criteria at Angiogram:
- Critical coronary artery stenosis in the vessel which is to be studied (\>90%).
- Left main stem coronary disease causing a \>50% stenosis.
- Triple vessel coronary disease.
Key Trial Info
Start Date :
December 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05346458
Start Date
December 14 2022
End Date
October 3 2023
Last Update
April 30 2024
Active Locations (1)
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1
St Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE