Clinical trial NCT05346458: Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor
Official title: A Single Centre, Prospective, Feasibility Study of the iKOs™ Coronary Pressure and Flow Rapid-exchange Microcatheter and iKOr™ Console in Patients With Coronary Heart Disease Undergoing Coronary Physiology Investigations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Coronary Microvascular Disease
Keywords: Heart
Microcatheter
Fibreoptic
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Echopoint Medical Ltd
First posted: 2022-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single centre, prospective, feasibility study of the iKOs™ coronary pressure and flow rapid-exchange microcatheter and iKOr™ console in patients with coronary heart disease undergoing coronary physiology investigations.
Primary purpose: DIAGNOSTIC

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 angiogram and pressure wire tests.

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 are assessed as eligible will undergo baseline assessments and preparation for their angiogram.

Once enrolled they will undergo coronary angiography at the start of their clinical procedure. The angiogram will be examined by the Investigator and a decision made if the target vessel is suitable for a pressure wire study and insertion of the investigational device. If the investigator confirms that the participant remains eligible and the study part can go ahead, the participant will proceed to undergo the investigation with the iKOs microcatheter.

The study assessments will be performed through the right radial artery (preference) under local anaesthesia. A sheath will be inserted and a pre-procedure blood sample taken for Troponin T level. A pressure study will then be performed, initially with a pressure wire before using the iKOs™ microcatheter. Both will be performed before and after hyperaemia. Following withdrawal of the iKOs™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn. The case will then proceed as clinically indicated. The whole procedure should take about 30-45 minutes. Post-procedure the participant will be managed according to standard clinical practice.

The participant will be discharged home, usually about 4 hours after the end of the procedure. A troponin blood test and ECG will be repeated before they are discharged.

Follow up telephone calls to assess for any complications of the procedure will be made within the first 7 days and again between 6 and 8 weeks after the procedure.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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.

Primary outcomes:
measure: To assess the effectiveness of the iKOr system in measuring temperature change (flow) in patients with coronary artery disease undergoing physiology investigations
timeFrame: Measured immediately prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).
Secondary outcomes:
measure: To assess the safety of the iKOs microcatheter in patients undergoing angiography and pressure wire assessment
timeFrame: Measured at procedure, at 4 hrs post procedure, at 1 week post procedure and 8 weeks post procedure
measure: To assess the safety of the iKOs microcatheter procedure
timeFrame: Measured at procedure, 4 hrs post procedure, at 1 week post procedure and 8 weeks post procedure
measure: To assess the effect of the iKOs microcatheter on cardiac injury
timeFrame: Troponin T measurement at procedure start and 4 hrs post procedure
measure: To assess the effect of the iKOs microcatheter on TIMI (Thrombolysis In Myocardial Infarction) flow
timeFrame: TIMI flow measured immediately prior to insertion of iKOs microcatheter and on removal of the iKOs microcatheter
Other outcomes:
measure: To examine the quality of the temperature recordings
timeFrame: Measured from just prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).
measure: To examine ease of use of the iKOs microcatheter
timeFrame: Measured at procedure - the time taken from insertion of iKOs microcatheter into guide cath to removal of iKOs microcatheter from guide cath
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
state: England
Study officials:
affiliation: Queen Mary University of London
name: Anthony Mathur
role: PRINCIPAL_INVESTIGATOR
References: