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

NCT05346458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-30

No results posted yet for this study

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

Interventions

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 A pressure wire assessment is repeated after the microcatheter is withdrawn.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.

Sponsors & Collaborators

  • Echopoint Medical Ltd

    collaborator UNKNOWN

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Anthony Mathur · Queen Mary University of London

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2023-08-22
Completion
2023-10-03

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05346458 on ClinicalTrials.gov