Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346458
• Other study ID #: 305877
• Status: Completed
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: October 3, 2023

Study information

• Verified date: April 2024
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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Following withdrawal of the iKOs™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 3, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Microvascular Disease
• Coronary Stenosis
• Microvascular Angina

Intervention

Device:
• Intra coronary rapid-exchange iKOs microcatheter intervention
Patients planned for an invasive coronary physiology (pressure-wire) study and who meet the inclusion criteria and none of the exclusion criteria can be enrolled. Participants will undergo preparation for their clinical procedure (angiogram with pressure wire study) in the normal manner. Arterial cannulation will be performed via the radial or femoral artery) under local anaesthesia. The sheath will be inserted and a pre-procedure blood sample taken for Troponin T level. A coronary angiogram will be performed as per standard clinical practice prior to cannulating the coronary artery to be studied. The pressure studies will be performed sequentially, first with a pressure wire before using the iKOs™ microcatheter. Following withdrawal of the iKOs™ microcatheter. A pressure wire assessment is repeated after the microcatheter is withdrawn. The case will then proceed as clinically indicated. Post-procedure the participant will be managed according to standard clinical practice.

Locations

Country	Name	City	State
United Kingdom	St Bartholomew's Hospital	London	England

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Echopoint Medical Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To examine the quality of the temperature recordings	The number of complete temperature measurement recordings and the number of interpretable temperature waveforms	Measured from just prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).
Other	To examine ease of use of the iKOs microcatheter	Time taken for deployment of the microcatheter	Measured at procedure - the time taken from insertion of iKOs microcatheter into guide cath to removal of iKOs microcatheter from guide cath
Primary	To assess the effectiveness of the iKOr system in measuring temperature change (flow) in patients with coronary artery disease undergoing physiology investigations	A change in thermal transit time measured by the iKOr system	Measured immediately prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).
Secondary	To assess the safety of the iKOs microcatheter in patients undergoing angiography and pressure wire assessment	The number of major adverse cardiac events or patient deaths	Measured at procedure, at 4 hrs post procedure, at 1 week post procedure and 8 weeks post procedure
Secondary	To assess the safety of the iKOs microcatheter procedure	The number of procedural complications related to the device (operator observed vessel spasm, vascular complications, bleeding)	Measured at procedure, 4 hrs post procedure, at 1 week post procedure and 8 weeks post procedure
Secondary	To assess the effect of the iKOs microcatheter on cardiac injury	The change in Troponin levels	Troponin T measurement at procedure start and 4 hrs post procedure
Secondary	To assess the effect of the iKOs microcatheter on TIMI (Thrombolysis In Myocardial Infarction) flow	The change in TIMI (Thrombolysis In Myocardial Infarction) flow	TIMI flow measured immediately prior to insertion of iKOs microcatheter and on removal of the iKOs microcatheter