Coronary Artery StenosisNCT04970082
A Study to Evaluate Direct Wire Pacing (DWP) for Measuring Fractional Flow Reserve (FFR)
A study testing FFR DWP and FFR in people with Coronary Artery Stenosis and Fractional Flow Reserve, run by Centre Recherche Cardio Vasculaire Alpes at 1 site in France.
Trial summary
This is a randomized, non-inferiority, crossover investigation comparing the Direct Wire Pacing (DWP) versus standard method to measure Fractional Flow Reserve (FFR) in subjects with FFR indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Fractional Flow Reserve
- What is being tested?
- FFR DWP and FFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2021to 31 Aug 2022
- 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
- The patients included in the study must meet the following inclusion criteria :
- Patients ≥ 18 years old
- Patients with FFR indications
- Has given consent to undergo diagnostic coronary procedure
- Patients able to understand and provide informed consent
- Patients with Social Security coverage
- Prior to randomisation: Angiography demonstrates at least one coronary stenosis in an artery, requiring FFR measurement for physiological assessment.
Who cannot join
- The patients included in the study should not meet the following inclusion criteria :
- Contraindications to use sensitivity to Adenosine or any of its excipients
- Technically inaccessible stenosis(es)
- Pregnant or breastfeeding woman
- Patients under judicial protection, tutorship or curatorship
- Patient participating in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Study to Evaluate and Compare the Reproducibility and Tolerability of Direct Wire Pacing for Measuring Fractional Flow Reserve Versus Standard Method in Subjects With FFR Indications
This is a randomized, non-inferiority, crossover investigation comparing the Direct Wire Pacing (DWP) versus standard method to measure Fractional Flow Reserve (FFR) in subjects with FFR indications.
All subjects requiring on a clinical basis a pressure wire assessment of coronary artery stenosis(es) will be eligible to take part in the study.
Read the detailed description
Pressure wire-based Fractional Flow Reserve (FFR) has become the reference standard index of haemodynamic significance to guide revascularisation of intermediate coronary artery lesions.
The FFR measurement determines the ratio of the maximum blood flow that can be achieved in a diseased or narrowed coronary artery to the maximum blood flow in a normal coronary artery. This ratio represents the potential decrease in distal coronary flow relative to coronary stenosis.
FFR is easily measured during routine coronary angiography using a pressure wire to calculate the ratio of coronary pressure distal to a stenosis or diseased segment to aortic pressure under conditions of maximum myocardial hyperemia. An FFR of 1.0 is widely accepted as normal. An FFR of less than 0.80 is generally considered to be associated with coronary ischemia and widely accepted in favor of revascularization rather than conservative management.
The current standard method of measuring FFR is to insert a pressure wire into the coronary artery while the hyperaemic agent, usually adenosine, is delivered by intracoronary bolus or continuous intravenous injection.
Administration of adenosine may cause bradycardia and thus cause patient vagal discomfort. Direct Wire Pacing (DWP) can potentially overcome the drawbacks of the standard method when measuring FFR. Indeed, DWP allows to transmit an electrical current from the external pacemaker to the heart thanks to metallic FFR guidewire already used, and thus prevent bradycardia.
In addition, there are some absolute contraindications to the use of Adenosine such as 2nd or 3rd degree atrioventricular block, untreated sinus dysfunction or long QT syndrome ...DWP could allow this highly recommended diagnostic tool (1A) to be used in this patient population.
The investigators would therefore like to determine if the measurement of FFR by DWP would be non-inferior to the standard method to obtain precise FFR values and maximize patient's comfort.
- Conditions
- Coronary Artery Stenosis, Fractional Flow Reserve
- Being tested
- FFR DWP, FFR
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR DWPDiagnostic test
FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.
FFRDiagnostic test
FFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method.
| Study group | Role | What they receive |
|---|---|---|
| FFR followed by FFR-DWP (investigation) | Experimental | The FFR measurement is performed with the standard method first followed by the FFR measurement with the DWP method. Receives: Diagnostic Test: FFR DWP; Diagnostic Test: FFR |
| FFR-DWP (investigation) followed by FFR | Experimental | The FFR measurement is performed with the DWP method first followed by the FFR measurement with the standard method. Receives: Diagnostic Test: FFR DWP; Diagnostic Test: FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the FFR measurement
Evaluated by the number of patients with comparable FFR ratio recording. The FFR ratio should remain constant (+/-0.02) between the two modes of measuring FFR.
Measured: Intraoperative
Secondary outcomes (3)
Number of participants with Adverse Events
Assessed by the number of participants with adverse events during the procedure.
Measured: Intraoperative
Tolerance
Assessed by asking patients during each FFR to grade verbally any symptoms of chest discomfort.
Measured: Intraoperative
correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory
The correlation between a disproportionately high FFR value in presence of a (partially)infarcted territory will be assessed by the comparison the obtained FFR value, the degree of angiographic stenosis measured and the obtained stimulation threshold.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start17 Jun 2021
- Primary completion4 Feb 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Recherche Cardio Vasculaire Alpes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Faurie, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970082
- Sponsor's protocol ID
- 2021-A00947-34
- Status last verified
- May 2022
- First submitted
- 16 Jul 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study to Evaluate and Compare the Reproducibility and Tolerability of Direct Wire Pacing for Measuring Fractional Flow Reserve Versus Standard Method in Subjects With FFR Indications
- ClinicalTrials.gov ID
- NCT04970082
- Acronym / sponsor ID
- 2021-A00947-34
- Conditions
- Coronary Artery Stenosis, Fractional Flow Reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Recherche Cardio Vasculaire AlpesUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 21 Jul 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.
This is a randomized, non-inferiority, crossover investigation comparing the Direct Wire Pacing (DWP) versus standard method to measure Fractional Flow Reserve (FFR) in subjects with FFR indications.
All subjects requiring on a clinical basis a pressure wire assessment of coronary artery stenosis(es) will be eligible to take part in the study.
Detailed description
Pressure wire-based Fractional Flow Reserve (FFR) has become the reference standard index of haemodynamic significance to guide revascularisation of intermediate coronary artery lesions.
The FFR measurement determines the ratio of the maximum blood flow that can be achieved in a diseased or narrowed coronary artery to the maximum blood flow in a normal coronary artery. This ratio represents the potential decrease in distal coronary flow relative to coronary stenosis.
FFR is easily measured during routine coronary angiography using a pressure wire to calculate the ratio of coronary pressure distal to a stenosis or diseased segment to aortic pressure under conditions of maximum myocardial hyperemia. An FFR of 1.0 is widely accepted as normal. An FFR of less than 0.80 is generally considered to be associated with coronary ischemia and widely accepted in favor of revascularization rather than conservative management.
The current standard method of measuring FFR is to insert a pressure wire into the coronary artery while the hyperaemic agent, usually adenosine, is delivered by intracoronary bolus or continuous intravenous injection.
Administration of adenosine may cause bradycardia and thus cause patient vagal discomfort. Direct Wire Pacing (DWP) can potentially overcome the drawbacks of the standard method when measuring FFR. Indeed, DWP allows to transmit an electrical current from the external pacemaker to the heart thanks to metallic FFR guidewire already used, and thus prevent bradycardia.
In addition, there are some absolute contraindications to the use of Adenosine such as 2nd or 3rd degree atrioventricular block, untreated sinus dysfunction or long QT syndrome ...DWP could allow this highly recommended diagnostic tool (1A) to be used in this patient population.
The investigators would therefore like to determine if the measurement of FFR by DWP would be non-inferior to the standard method to obtain precise FFR values and maximize patient's comfort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR followed by FFR-DWP (investigation) | Experimental | Diagnostic Test: FFR DWP, Diagnostic Test: FFRThe FFR measurement is performed with the standard method first followed by the FFR measurement with the DWP method. |
| FFR-DWP (investigation) followed by FFR | Experimental | Diagnostic Test: FFR DWP, Diagnostic Test: FFRThe FFR measurement is performed with the DWP method first followed by the FFR measurement with the standard method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years old
- Patients with FFR indications
- Has given consent to undergo diagnostic coronary procedure
- Patients able to understand and provide informed consent
- Patients with Social Security coverage
Key exclusion criteria (6 listed)
- Contraindications to use sensitivity to Adenosine or any of its excipients
- Technically inaccessible stenosis(es)
- Pregnant or breastfeeding woman
- Patients under judicial protection, tutorship or curatorship
- Patient participating in another interventional clinical trial
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 |
|---|---|---|
| FFR DWPFFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method. | Diagnostic test | FFR followed by FFR-DWP (investigation), FFR-DWP (investigation) followed by FFR |
| FFRFFR will be measured twice in the same lesion : One with the standard method and the other with the DWP method. | Diagnostic test | FFR followed by FFR-DWP (investigation), FFR-DWP (investigation) followed by FFR |
Primary outcome
Reproducibility of the FFR measurement
Time frame: Intraoperative
Evaluated by the number of patients with comparable FFR ratio recording. The FFR ratio should remain constant (+/-0.02) between the two modes of measuring FFR.
3 secondary outcomes
Number of participants with Adverse Events
Time frame: Intraoperative
Tolerance
Time frame: Intraoperative
correlation between a disproportionately high FFR value and la presence of a (partially) infarcted territory
Time frame: Intraoperative
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 15 Dec 2023.
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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.
Benjamin Faurie principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR DWP and FFR in people with Coronary Artery Stenosis and Fractional Flow Reserve, run by Centre Recherche Cardio Vasculaire Alpes at 1 site in France.
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 7 inclusion and 6 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 15 Dec 2023. 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 France. 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?
Reproducibility of the FFR measurement (time frame: Intraoperative). 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 15 Dec 2023.