Coronary DiseaseNCT04776577
Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath
A study testing Wirecath@ and Abbott PressureWire® (20 patients), Wirecath® (20 patients) and Coronary flow reserve in people with Coronary Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
In summary, the purpose of the study is to evaluate whether the Wirecath device can be used as a standard pressure wire in a safe and efficient way. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Wirecath@ and Abbott PressureWire® (20 patients), Wirecath® (20 patients) and Coronary flow reserve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2021to 25 Oct 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18yrs age)
- Informed consent given
- Patients with result from diagnostic angiography
- Indication for coronary pressure assessment
Who cannot join
- Patients with known Heparin-Induced Thrombocytopenia (HIT) or allergy to heparin.
- Inability to tolerate Adenosine
- Any condition, e.g. unstable health, which in the opinion of the investigator makes the patient unsuitable for inclusion (Decision documented in inclusion log).
Trial locations and contacts
1 site in 1 country.
About this study
In summary, the purpose of the study is to evaluate whether the Wirecath device can be used as a standard pressure wire in a safe and efficient way.
Read the detailed description
Simultaneous measurements study (group 1) This group will be recruited and assessed in parallel with recruitment to group 2 at the discretion of the treating physician, based on the resource availability in the cath lab.
In the simultaneous measurements study group, measurements will be collected from a Wirecath® and a regular sensor-tipped pressure wire in the same position in the coronary artery at the same time (simultaneously). The regular wire to be used is the market leading Abbott PressureWire®.
By comparing the pressure measurements (Pd) from Wirecath® and from a regular sensor-tipped wire, we intend to examine if the pressure reported by the two wires deviate in any way. If a deviation exists, the hydrostatic error, caused by the height difference between the positions of Pa and Pd when using a sensor-tipped wire, will be assessed.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
- first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and
- second together with a Hexacath/Rayflow@ infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).
Wirecath will be used for PCI when indicated and performance documented by follow-up questions to the users.
Regular study group (group 2) In the regular use study group, the Wirecath® is to be used as a regular pressure measurement tool, replacing the regularly used pressure wire.
Pressure measurement results will be collected.
Wirecath® will be used for PCI when indicated and performance documented by follow-up questions to the users.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
- first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and
- second together with a Hexacath/Rayflow® infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).
Echocardiography-CFR group (group 3) Patients from group 1 and group 2 that have undergone Bolus-thermo and Absolute-flow CFR measurements, will be recruited to group 3. In this group echocardiography-CFR (Echo CFR) will be measured within 14 days. The echocardiography is performed according to the standard procedure of the hospital. The correlation between the methods will be investigated.
- Conditions
- Coronary Disease
- Being tested
- Wirecath@ and Abbott PressureWire® (20 patients), Wirecath® (20 patients), Coronary flow reserve
- Keywords
- coronary disease, fractional flow reserve, coronary flow reserve, pressure wire
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wirecath@ and Abbott PressureWire® (20 patients)Device
Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire®
Wirecath® (20 patients)Device
FFR measurement with Wirecath® only
Coronary flow reserveDevice
Pressure derived CFR with Wirecath®, Thermodilution CFR with Abbott PressureWire®, Absolut flow CFR with Abbott PressureWire® and Hexacath Rayflow catheter®, Non-invasive echo derived CFR
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Other | Group 1 and group 2 will be recruited and assessed in parallel at the discretion of the treating physician, based on the characteristics of the patient. Group 3 will be recruited from suitable patients in group 1 and 2.
Simultaneous measurements study (group 1) Regular study group (group 2) Echocardiography-CFR group (group 3) Receives: Device: Wirecath@ and Abbott PressureWire® (20 patients); Device: Wirecath® (20 patients); Device: Coronary flow reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events
The safety of the Wirecath@ will be assessed through the frequency and severity of all adverse events reported for study subjects after the completion of the pressure measurement and PCI. The primary endpoint will be achieved when the device has been used on enrolled patients and required measurements have been taken.
Measured: 30-60 minutes
Secondary outcomes (2)
Comparison with Abbott pressure wire
comparing the Wirecath measurement values with the measurement values of a regular sensor-tipped pressure guidewire during simultaneous measurements in the same vessel.
Measured: 30-60 minutes
Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR
In FFR negative LADs, comparing the Wirecath® pressure-derived CFR values with CFR derived from thermodilution, absolute flow and echocardiography-CFR values. This secondary endpoint will be achieved if these values correlate
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 Feb 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Results from simultaneous measurements with two wires will be graphically showed using the Bland-Altman plot and reported in terms of intraclass correlation coefficient (ICC). Also, whether a theoretical correction for the expected hydrostatic pressure error (0.77 mmHg per cm height difference) at the distal pressure measurement site (Pd) accounts for the difference in FFR during simultaneous measurements will be explored, and a corrected ICC reported. A two-sided p-value of \<0.05 will be considered to be significant, when applicable. The Pearson's correlation coefficient will be also calculated considering the Wirecath FFR value in comparison to the FFR value made with the regular wire with and without correction for hydrostatic error. For the CFR values, the Pearson's correlation coefficient will be used to determine the relation between the bolus-thermo CFR, absolute-flow CFR, Echo CFR and the pressure-derived CFR in the LAD.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Cavis Technologies AB
- Responsible party
- Sponsor
- Investigators
- Oskar Angerås, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776577
- Sponsor's protocol ID
- 0100P
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramunddal T, Dworeck C, Torild P, Andreen S, Gan LM, Hirlekar G, Ioanes D, Myredal A, Odenstedt J, Petursson P, Pylova T, Topel F, Volz S, Hilmersson M, Redfors B, Angeras O. Safety and Feasibility Using a Fluid-Filled Wire to Avoid Hydrostatic Errors in Physiological Intracoronary Measurements. Cardiol Res Pract. 2024 Jan 2;2024:6664482. doi: 10.1155/2024/6664482. eCollection 2024.
PubMed 38204600
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coronary Pressure Using the Combined Guidewire and Catheter Wirecath
- ClinicalTrials.gov ID
- NCT04776577
- Acronym / sponsor ID
- 0100P
- Conditions
- Coronary Disease
- Keywords
- coronary disease, fractional flow reserve, coronary flow reserve, pressure wire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Cavis Technologies AB
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 1 Mar 2021 (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.
In summary, the purpose of the study is to evaluate whether the Wirecath device can be used as a standard pressure wire in a safe and efficient way.
Detailed description
Simultaneous measurements study (group 1) This group will be recruited and assessed in parallel with recruitment to group 2 at the discretion of the treating physician, based on the resource availability in the cath lab.
In the simultaneous measurements study group, measurements will be collected from a Wirecath® and a regular sensor-tipped pressure wire in the same position in the coronary artery at the same time (simultaneously). The regular wire to be used is the market leading Abbott PressureWire®.
By comparing the pressure measurements (Pd) from Wirecath® and from a regular sensor-tipped wire, we intend to examine if the pressure reported by the two wires deviate in any way. If a deviation exists, the hydrostatic error, caused by the height difference between the positions of Pa and Pd when using a sensor-tipped wire, will be assessed.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
- first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and
- second together with a Hexacath/Rayflow@ infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).
Wirecath will be used for PCI when indicated and performance documented by follow-up questions to the users.
Regular study group (group 2) In the regular use study group, the Wirecath® is to be used as a regular pressure measurement tool, replacing the regularly used pressure wire.
Pressure measurement results will be collected.
Wirecath® will be used for PCI when indicated and performance documented by follow-up questions to the users.
In FFR-negative patients, after removal of the Wirecath®, the Abbott PressureWire® is used in LAD
- first to measure CFR by saline bolus injections and thermodilution during rest and hyperemia (Bolus-thermo CFR) and
- second together with a Hexacath/Rayflow® infusion catheter and a saline infusion pump to measure absolute flow during rest and hyperemia that will be used to calculate CFR (Absolute-flow CFR).
Echocardiography-CFR group (group 3) Patients from group 1 and group 2 that have undergone Bolus-thermo and Absolute-flow CFR measurements, will be recruited to group 3. In this group echocardiography-CFR (Echo CFR) will be measured within 14 days. The echocardiography is performed according to the standard procedure of the hospital. The correlation between the methods will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Results from simultaneous measurements with two wires will be graphically showed using the Bland-Altman plot and reported in terms of intraclass correlation coefficient (ICC). Also, whether a theoretical correction for the expected hydrostatic pressure error (0.77 mmHg per cm height difference) at the distal pressure measurement site (Pd) accounts for the difference in FFR during simultaneous measurements will be explored, and a corrected ICC reported. A two-sided p-value of <0.05 will be considered to be significant, when applicable. The Pearson's correlation coefficient will be also calculated considering the Wirecath FFR value in comparison to the FFR value made with the regular wire with and without correction for hydrostatic error. For the CFR values, the Pearson's correlation coefficient will be used to determine the relation between the bolus-thermo CFR, absolute-flow CFR, Echo CFR and the pressure-derived CFR in the LAD.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Other | Device: Wirecath@ and Abbott PressureWire® (20 patients), Device: Wirecath® (20 patients), Device: Coronary flow reserveGroup 1 and group 2 will be recruited and assessed in parallel at the discretion of the treating physician, based on the characteristics of the patient. Group 3 will be recruited from suitable patients in group 1 and 2. Simultaneous measurements study (group 1) Regular study group (group 2) Echocardiography-CFR group (group 3) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>18yrs age)
- Informed consent given
- Patients with result from diagnostic angiography
- Indication for coronary pressure assessment
Key exclusion criteria (3 listed)
- Patients with known Heparin-Induced Thrombocytopenia (HIT) or allergy to heparin.
- Inability to tolerate Adenosine
- Any condition, e.g. unstable health, which in the opinion of the investigator makes the patient unsuitable for inclusion (Decision documented in inclusion log).
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 |
|---|---|---|
| Wirecath@ and Abbott PressureWire® (20 patients)Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire® | Device | Study arm |
| Wirecath® (20 patients)FFR measurement with Wirecath® only | Device | Study arm |
| Coronary flow reservePressure derived CFR with Wirecath®, Thermodilution CFR with Abbott PressureWire®, Absolut flow CFR with Abbott PressureWire® and Hexacath Rayflow catheter®, Non-invasive echo derived CFR | Device | Study arm |
Primary outcome
Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events
Time frame: 30-60 minutes
The safety of the Wirecath@ will be assessed through the frequency and severity of all adverse events reported for study subjects after the completion of the pressure measurement and PCI. The primary endpoint will be achieved when the device has been used on enrolled patients and required measurements have been taken.
2 secondary outcomes
Comparison with Abbott pressure wire
Time frame: 30-60 minutes
Comparing pressure-derived coronary flow reserve (CFR) with bolus-thermo CFR, absolute flow CFR and non-invasive doppler derived CFR
Time frame: 14 days
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 9 Jan 2024.
- Derived from this study: PubMed 38204600Ramunddal T, Dworeck C, Torild P, Andreen S, Gan LM, Hirlekar G, Ioanes D, Myredal A, Odenstedt J, Petursson P, Pylova T, Topel F, Volz S, Hilmersson M, Redfors B, Angeras O. Safety and Feasibility Using a Fluid-Filled Wire to Avoid Hydrostatic Errors in Physiological Intracoronary Measurements. Cardiol Res Pract. 2024 Jan 2;2024:6664482. doi: 10.1155/2024/6664482. eCollection 2024.
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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.
Oskar Angerås, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wirecath@ and Abbott PressureWire® (20 patients), Wirecath® (20 patients) and Coronary flow reserve in people with Coronary Disease, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 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 9 Jan 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 Sweden. 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?
Safety of the Wirecath® will be assessed through the frequency and severity of all adverse events (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776577, which also lists 1 linked publication.
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 9 Jan 2024.