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

NCT05346458 | Completed DMC

• 1 other identifier: 305877
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Microvascular Disease

Keywords

Heart; Microcatheter; Fibreoptic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To assess the safety of the iKOs microcatheter in patients undergoing angiography and pressure wire assessment

  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

  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

  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

  TIMI flow measured immediately prior to insertion of iKOs microcatheter and on removal of the iKOs microcatheter

Other Outcomes (2)

• To examine the quality of the temperature recordings

  Measured from just prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).

• To examine ease of use of the iKOs microcatheter

  Measured at procedure - the time taken from insertion of iKOs microcatheter into guide cath to removal of iKOs microcatheter from guide cath

Study Arms (1)

Intra coronary rapid-exchange iKOs microcatheter intervention

EXPERIMENTAL

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

Interventions

Intra coronary rapid-exchange iKOs microcatheter intervention 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.

Also known as: iKOs Microcatheter

Intra coronary rapid-exchange iKOs microcatheter intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Echopoint Medical Ltd: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Microvascular Angina

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris

Study Officials

• Anthony Mathur

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 9, 2022
• First Posted: April 26, 2022
• Study Start: December 14, 2022
• Primary Completion: August 22, 2023
• Study Completion: October 3, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)