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

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withdrawal of the iKOs™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn.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

Official Title
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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

Conditions
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Coronary Artery Disease, Coronary Stenosis, Coronary Microvascular Disease

Intervention / Treatment
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* Device: Intra coronary rapid-exchange iKOs microcatheter intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra coronary rapid-exchange iKOs microcatheter intervention<br>Patients with coronary heart disease and undergoing coronary physiology investigations (pressure wire measurements) will have additional coronary pressure and flow measurements using the iKOs rapid-exchange microcatheter and iKOr console. | Device: Intra coronary rapid-exchange iKOs microcatheter intervention<br>* 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.<br>* Other names: iKOs Microcatheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart, Microcatheter, Fibreoptic