Coronary Artery DiseaseNCT05346458
Measuring Blood Flow in Heart Vessels With a New Fibre Optic Sensor
A study testing Intra coronary rapid-exchange iKOs microcatheter intervention in people with Coronary Artery Disease and Coronary Stenosis, run by Queen Mary University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Coronary Microvascular Disease
- What is being tested?
- Intra coronary rapid-exchange iKOs microcatheter intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2022to 3 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's Hospital
London, England, EC1A 7BE
About this study
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
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.
Read the 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.
- Being tested
- Intra coronary rapid-exchange iKOs microcatheter intervention
- Keywords
- Heart, Microcatheter, Fibreoptic
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra coronary rapid-exchange iKOs microcatheter interventionDevice
Also called iKOs Microcatheter
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intra coronary rapid-exchange iKOs microcatheter intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
The number of major adverse cardiac events or patient deaths
Measured: 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: 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
Measured: 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
Measured: TIMI flow measured immediately prior to insertion of iKOs microcatheter and on removal of the iKOs microcatheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start14 Dec 2022
- Primary completion22 Aug 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Echopoint Medical Ltd
- Responsible party
- Sponsor
- Investigators
- Anthony Mathur, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346458
- Sponsor's protocol ID
- 305877
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05346458
- Acronym / sponsor ID
- 305877
- Keywords
- Heart, Microcatheter, Fibreoptic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Echopoint Medical Ltd
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intra coronary rapid-exchange iKOs microcatheter intervention | Experimental | Device: Intra coronary rapid-exchange iKOs microcatheter interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra coronary rapid-exchange iKOs microcatheter interventionAlso: iKOs MicrocatheterPatients 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. | Device | Intra coronary rapid-exchange iKOs microcatheter intervention |
Primary outcome
To assess the effectiveness of the iKOr system in measuring temperature change (flow) in patients with coronary artery disease undergoing physiology investigations
Time frame: Measured immediately prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).
A change in thermal transit time measured by the iKOr system
4 secondary outcomes
To assess the safety of the iKOs microcatheter in patients undergoing angiography and pressure wire assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: TIMI flow measured immediately prior to insertion of iKOs microcatheter and on removal of the iKOs microcatheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mathur principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra coronary rapid-exchange iKOs microcatheter intervention in people with Coronary Artery Disease and Coronary Stenosis, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of the iKOr system in measuring temperature change (flow) in patients with coronary artery disease undergoing physiology investigations (time frame: Measured immediately prior to adenosine administration (baseline), and during adenosine administration (hyperaemia).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.