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

NCT ID: NCT05346458

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-10-03

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withdrawal of the iKOs™ microcatheter, a pressure wire assessment is then repeated after the microcatheter is withdrawn.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

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Microvascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intra coronary rapid-exchange iKOs microcatheter intervention

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.

Group Type: EXPERIMENTAL

Intra coronary rapid-exchange iKOs microcatheter intervention

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

iKOs Microcatheter

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Echopoint Medical Ltd

UNKNOWN

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Mathur

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

St Bartholomew's Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

305877

Identifier Type: -

Identifier Source: org_study_id