Coronary Artery DiseaseTarget-FFRNCT03259815
An Evaluation of a Physiology-guided PCI Optimisation Strategy
A study testing P.I.O.S. and Pre and post-PCI coronary physiology measurements in people with Coronary Artery Disease and Coronary Stenosis, run by NHS National Waiting Times Centre Board at 1 site in United Kingdom.
Trial summary
There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the available data suggest that despite… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- P.I.O.S. and Pre and post-PCI coronary physiology measurements
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2018to 4 Dec 2020
- 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
- Patients >18 years of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.
Who cannot join
- PCI in a coronary artery bypass graft
- PCI to an in-stent restenosis (ISR) lesion
- PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
- Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
- Severe cardiomyopathy (ejection fraction <30%).
- Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? - a Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)
There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the available data suggest that despite angiographically satisfactory results, this is actually achieved in less than 40% of cases.
The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artefact of pressure wire technology).
Read more
Using post-PCI FFR to guide stent optimisation and/or further intervention in the target vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results (and therefore presumably better clinical outcomes). However, there are additional costs involved in the routine use of post-PCI FFR and it is not clear just how often it is even possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.
The investigators propose a prospective study to assess the feasibility of achieving post-PCI FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The investigators anticipate using the data from this developmental study to support a subsequent funding application for a definitive phase 3 study of the impact of FFR targeted PCI on clinical outcomes.
Read the detailed description
Original hypothesis
A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40% to 60%.
Experimental details and design of proposed investigation
Overall aim:
A randomised controlled trial of a physiology-guided optimisation strategy to determine the feasibility of increasing the proportion of post-PCI FFR measurements ≥0.90 in a consecutive series of patients undergoing standard PCI procedures.
Study Population:
260 consecutive patients with stable angina referred for invasive management to the cardiac catheterisation lab who have been selected to undergo PCI based on either angiographic appearances or prior FFR assessment. Patients will be caffeine free for >12 hours pre-procedure.
Methods/Design:
Informed consent will be obtained prior to cardiac catheterisation in all potential subjects conforming to the inclusion and exclusion criteria.
Patients will then be randomised to one of two groups (described below) and PCI will be performed, using a pressure guidewire, according to standard practice at the Golden Jubilee National Hospital (including lesion pre-dilation and post-dilation of the stented segment).
Group 1 (PIOS Group):
Operator-blinded coronary physiology measurements will be recorded pre and post PCI.
If the post-PCI FFR is ≥0.90, no further intervention will be performed and the procedure is considered complete.
If post-PCI FFR is <0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback during a standard peripheral intravenous adenosine infusion (140mcg/kg/min) will be performed. Depending on the result the operator would then have the following options:
- If there is a step-up of ≥0.05 across the stented segment(s) further post-dilatation with a 0.25 - 0.50mm larger non-compliant balloon to at least 18 atmospheres should be performed followed by repeat FFR. Alternatively, the operator may choose to employ intracoronary imaging (IVUS or OCT) to guide post-dilation/optimisation of the stented segment.
- If there is a step-up of ≥0.05 across a relatively focal (<20mm) unstented segment which is technically suitable for further stenting then a further stent should be implanted followed by repeat FFR.
- If the FFR remains <0.90 after steps A +/- B, a further FFR pullback will be performed. If the criteria for Step B are again met, one additional stent may be deployed and a final FFR pullback performed. Following this, the FFR result will be accepted.
- If the residual pressure gradient is interpreted to reflect diffuse atherosclerosis with no focal step-ups, the result is accepted.
- At the end of the procedure the pressure wire sensor will be withdrawn to the tip of the guiding catheter and compared with the aortic pressure. A pressure drift of ≤0.03 will be accepted and the final FFR result adjusted accordingly.
- If there is a drift of ≥0.04, the wire should be re-equalised and the final FFR measurement be repeated.
- The patients will have their demographics and procedure details recorded. All patients will be asked to complete follow-up questionnaires at 3 months.
Group 2 (Control Group):
Pre and post-PCI coronary physiology measurements will be recorded but not disclosed to the operator. The angiographically defined result will be accepted. The patients will have their demographics and procedure details recorded. All patients will be asked to complete follow-up questionnaires at 3 months.
Expected value of results
- Confirmation that the proposed PIOS protocol significantly increases the proportion of patients obtaining a physiologically optimal post-PCI result will demonstrate the feasibility of this strategy and should lead to an increase in post-PCI pressure wire usage to achieve physiologically optimal results for patients. The investigators hypothesise that the PIOS intervention can increase the proportion of patients achieving this target from 40% to 60% and believe that an increment of at least this magnitude would be necessary to make a future larger study with both patient-oriented clinical (target vessel failure) and health care system (resource utilisation) outcomes acceptable to the interventional cardiology community and potential funders.
- The secondary outcome measures, albeit underpowered for clinical outcomes in this study, will hopefully still give a signal that achieving a target post-PCI FFR ≥0.90 does yield objective benefits for patients. This could then form the basis for a larger phase 3 trial to confirm improved clinical outcomes and cost- effectiveness of FFR-targeted PCI
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Being tested
- P.I.O.S., Pre and post-PCI coronary physiology measurements
- Keywords
- FFR Targeted PCI, Post-PCI FFR, Physiology-guided PCI Optimisation
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.I.O.S.Procedure or surgery
Physiologically-Guided Incremental Optimisation Strategy
Pre and post-PCI coronary physiology measurementsDiagnostic test
Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator
| Study group | Role | What they receive |
|---|---|---|
| PIOS Intervention Group | Experimental | Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is <0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min).
The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result. Receives: Procedure: P.I.O.S.; Diagnostic Test: Pre and post-PCI coronary physiology measurements |
| Control Group | Active comparator | Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted. Receives: Diagnostic Test: Pre and post-PCI coronary physiology measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a final post-PCI FFR result ≥0.90
The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
Measured: 1 day
Secondary outcomes (22)
The proportion of patients with final post-PCI FFR ≤0.80
The proportion of patients with a final post-PCI FFR result ≤0.80 will be compared between the randomised groups
Measured: 1 day
Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.
Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 3 months post PCI
Measured: 3 months
Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.
Patients will complete the EQ-5D questionnaire at baseline pre-procedure and again at 3 months post PCI
Measured: 3 months
The rate of target vessel failure (TVF) and its component features at 3 months.
Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.
Measured: 3 months
The rate of target vessel failure (TVF) and its component features at 1 year.
Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.
Measured: 1 year
Change from baseline in the FFR following PCI
The difference between measurements of Fractional Flow Reserve taken in the target vessel pre- and post-PCI
Measured: 1 day
The proportion of patients with final post-PCI dPR ≥0.90
The proportion of patients with a final post-PCI Diastolic Pressure Ratio (dPR) value ≥0.90
Measured: 1 day
Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI
The difference between measurements of the Diastolic Pressure Ratio taken in the target vessel pre and post PCI
Measured: 1 day
The proportion of patients with final post-PCI RFR ≥0.90
The proportion of patients with a final post-PCI Resting Full-cycle Ratio (RFR) value ≥0.90
Measured: 1 day
Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI
The difference between measurements of the Resting Full-Cycle Ratio (the lowest Pd/Pa ratio during the whole cardiac cycle at rest) taken in the target vessel pre and post PCI
Measured: 1 day
Change in TTrest following PCI
Change of the thermodilution-derived resting transit time (TTrest) from pre-PCI to final post-PCI value
Measured: 1 day
Change in TThyp following PCI
Change of the thermodilution-derived hyperaemic transit time (TThyp) from pre-PCI to final post-PCI value
Measured: 1 day
The proportion of patients with final post-PCI CFR value ≥2.0
The proportion of patients with a final post-PCI Coronary Flow Reserve (CFR) result ≥2.0
Measured: 1 day
Change from baseline in the Coronary Flow Reserve (CFR) following PCI
The difference between measurements of Coronary Flow Reserve taken in the target vessel pre and post PCI
Measured: 1 day
The proportion of patients with final post-PCI IMR >25
The proportion of patients with a final post-PCI Index of Microcirculatory Resistance (IMR) value >25
Measured: 1 day
Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI
The difference between measurements of IMR taken in the target vessel pre and post PCI
Measured: 1 day
The proportion of patients with final post-PCI IMRc >25
The proportion of patients with a final post-PCI corrected Index of Microcirculatory Resistance (IMRc) value >25
Measured: 1 day
Procedure Duration
The time required to perform the PIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
The cost of additional equipment employed in the experimental arm
The cost of additional equipment employed in the PIOS intervention (i.e. balloons/stents/intra-coronary imaging).
Measured: 1 day
Fluoroscopy Dose
The radiation doses for the PIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
Contrast Material Dose
The contrast material doses for the PIOS intervention procedures will be compared with those in the control group.
Measured: 1 day
Incidence of procedural complications such as coronary artery dissection or perforation.
The incidence of procedural complications such as coronary artery dissection or perforation will be recorded and compared between the two study arms
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start8 Mar 2018
- Primary completion22 Nov 2019
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board
- Investigators
- Keith G Oldroyd, MB, MD, Principal investigator, NHS National Waiting Times Centre Board (NHS Golden Jubilee)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259815
- Sponsor's protocol ID
- 17/CARD/10
- Other IDs
- IRAS ID 223780
- Acronym
- Target-FFR
- Status last verified
- Mar 2022
- First submitted
- 9 Aug 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.
PubMed 32037592Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
PubMed 34279606Seki R, Collison D, Ikeda K, Sonck J, Munhoz D, Bertolone DT, Ko B, Maeng M, Otake H, Koo BK, Storozhenko T, Bouisset F, Belmonte M, Leone A, Shumkova M, Ford TJ, Mahendiran T, Berry C, De Bruyne B, Oldroyd K, Sakai K, Mizukami T, Collet C. Validation of virtual fractional flow reserve pullback curves. Catheter Cardiovasc Interv. 2024 Nov;104(6):1178-1188. doi: 10.1002/ccd.31222. Epub 2024 Sep 29.
PubMed 39342486Collison D, Copt S, Mizukami T, Collet C, McLaren R, Didagelos M, Aetesam-Ur-Rahman M, McCartney P, Ford TJ, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Angina After Percutaneous Coronary Intervention: Patient and Procedural Predictors. Circ Cardiovasc Interv. 2023 Apr;16(4):e012511. doi: 10.1161/CIRCINTERVENTIONS.122.012511. Epub 2023 Mar 28.
PubMed 36974680Collet C, Collison D, Mizukami T, McCartney P, Sonck J, Ford T, Munhoz D, Berry C, De Bruyne B, Oldroyd K. Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2506-2518. doi: 10.1016/j.jcin.2022.09.048. Epub 2022 Nov 30.
PubMed 36543445
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? - a Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)
- ClinicalTrials.gov ID
- NCT03259815
- Acronym / sponsor ID
- Target-FFR / 17/CARD/10
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Keywords
- FFR Targeted PCI, Post-PCI FFR, Physiology-guided PCI Optimisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 24 Aug 2017 (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.
There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the available data suggest that despite angiographically satisfactory results, this is actually achieved in less than 40% of cases.
The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artefact of pressure wire technology).
Using post-PCI FFR to guide stent optimisation and/or further intervention in the target vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results (and therefore presumably better clinical outcomes). However, there are additional costs involved in the routine use of post-PCI FFR and it is not clear just how often it is even possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.
The investigators propose a prospective study to assess the feasibility of achieving post-PCI FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The investigators anticipate using the data from this developmental study to support a subsequent funding application for a definitive phase 3 study of the impact of FFR targeted PCI on clinical outcomes.
Detailed description
Original hypothesis
A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40% to 60%.
Experimental details and design of proposed investigation
Overall aim:
A randomised controlled trial of a physiology-guided optimisation strategy to determine the feasibility of increasing the proportion of post-PCI FFR measurements ≥0.90 in a consecutive series of patients undergoing standard PCI procedures.
Study Population:
260 consecutive patients with stable angina referred for invasive management to the cardiac catheterisation lab who have been selected to undergo PCI based on either angiographic appearances or prior FFR assessment. Patients will be caffeine free for >12 hours pre-procedure.
Methods/Design:
Informed consent will be obtained prior to cardiac catheterisation in all potential subjects conforming to the inclusion and exclusion criteria.
Patients will then be randomised to one of two groups (described below) and PCI will be performed, using a pressure guidewire, according to standard practice at the Golden Jubilee National Hospital (including lesion pre-dilation and post-dilation of the stented segment).
Group 1 (PIOS Group):
Operator-blinded coronary physiology measurements will be recorded pre and post PCI.
If the post-PCI FFR is ≥0.90, no further intervention will be performed and the procedure is considered complete.
If post-PCI FFR is <0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback during a standard peripheral intravenous adenosine infusion (140mcg/kg/min) will be performed. Depending on the result the operator would then have the following options:
- If there is a step-up of ≥0.05 across the stented segment(s) further post-dilatation with a 0.25 - 0.50mm larger non-compliant balloon to at least 18 atmospheres should be performed followed by repeat FFR. Alternatively, the operator may choose to employ intracoronary imaging (IVUS or OCT) to guide post-dilation/optimisation of the stented segment.
- If there is a step-up of ≥0.05 across a relatively focal (<20mm) unstented segment which is technically suitable for further stenting then a further stent should be implanted followed by repeat FFR.
- If the FFR remains <0.90 after steps A +/- B, a further FFR pullback will be performed. If the criteria for Step B are again met, one additional stent may be deployed and a final FFR pullback performed. Following this, the FFR result will be accepted.
- If the residual pressure gradient is interpreted to reflect diffuse atherosclerosis with no focal step-ups, the result is accepted.
- At the end of the procedure the pressure wire sensor will be withdrawn to the tip of the guiding catheter and compared with the aortic pressure. A pressure drift of ≤0.03 will be accepted and the final FFR result adjusted accordingly.
- If there is a drift of ≥0.04, the wire should be re-equalised and the final FFR measurement be repeated.
- The patients will have their demographics and procedure details recorded. All patients will be asked to complete follow-up questionnaires at 3 months.
Group 2 (Control Group):
Pre and post-PCI coronary physiology measurements will be recorded but not disclosed to the operator. The angiographically defined result will be accepted. The patients will have their demographics and procedure details recorded. All patients will be asked to complete follow-up questionnaires at 3 months.
Expected value of results
- Confirmation that the proposed PIOS protocol significantly increases the proportion of patients obtaining a physiologically optimal post-PCI result will demonstrate the feasibility of this strategy and should lead to an increase in post-PCI pressure wire usage to achieve physiologically optimal results for patients. The investigators hypothesise that the PIOS intervention can increase the proportion of patients achieving this target from 40% to 60% and believe that an increment of at least this magnitude would be necessary to make a future larger study with both patient-oriented clinical (target vessel failure) and health care system (resource utilisation) outcomes acceptable to the interventional cardiology community and potential funders.
- The secondary outcome measures, albeit underpowered for clinical outcomes in this study, will hopefully still give a signal that achieving a target post-PCI FFR ≥0.90 does yield objective benefits for patients. This could then form the basis for a larger phase 3 trial to confirm improved clinical outcomes and cost- effectiveness of FFR-targeted PCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| PIOS Intervention Group | Experimental | Procedure: P.I.O.S., Diagnostic Test: Pre and post-PCI coronary physiology measurementsOperator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is <0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min). The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result. |
| Control Group | Active comparator | Diagnostic Test: Pre and post-PCI coronary physiology measurementsOperator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.
Key exclusion criteria (7 listed)
- PCI in a coronary artery bypass graft
- PCI to an in-stent restenosis (ISR) lesion
- PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
- Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
- Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
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 |
|---|---|---|
| P.I.O.S.Physiologically-Guided Incremental Optimisation Strategy | Procedure or surgery | PIOS Intervention Group |
| Pre and post-PCI coronary physiology measurementsPre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator | Diagnostic test | Control Group, PIOS Intervention Group |
Primary outcome
The proportion of patients with a final post-PCI FFR result ≥0.90
Time frame: 1 day
The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
22 secondary outcomes
The proportion of patients with final post-PCI FFR ≤0.80
Time frame: 1 day
Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.
Time frame: 3 months
Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.
Time frame: 3 months
The rate of target vessel failure (TVF) and its component features at 3 months.
Time frame: 3 months
The rate of target vessel failure (TVF) and its component features at 1 year.
Time frame: 1 year
Change from baseline in the FFR following PCI
Time frame: 1 day
The proportion of patients with final post-PCI dPR ≥0.90
Time frame: 1 day
Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI
Time frame: 1 day
The proportion of patients with final post-PCI RFR ≥0.90
Time frame: 1 day
Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI
Time frame: 1 day
Change in TTrest following PCI
Time frame: 1 day
Change in TThyp following PCI
Time frame: 1 day
The proportion of patients with final post-PCI CFR value ≥2.0
Time frame: 1 day
Change from baseline in the Coronary Flow Reserve (CFR) following PCI
Time frame: 1 day
The proportion of patients with final post-PCI IMR >25
Time frame: 1 day
Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI
Time frame: 1 day
The proportion of patients with final post-PCI IMRc >25
Time frame: 1 day
Procedure Duration
Time frame: 1 day
The cost of additional equipment employed in the experimental arm
Time frame: 1 day
Fluoroscopy Dose
Time frame: 1 day
Contrast Material Dose
Time frame: 1 day
Incidence of procedural complications such as coronary artery dissection or perforation.
Time frame: 1 day
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 31 Mar 2022.
- Background: PubMed 32037592Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.
- Results publication: PubMed 34279606Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
- Derived from this study: PubMed 39342486Seki R, Collison D, Ikeda K, Sonck J, Munhoz D, Bertolone DT, Ko B, Maeng M, Otake H, Koo BK, Storozhenko T, Bouisset F, Belmonte M, Leone A, Shumkova M, Ford TJ, Mahendiran T, Berry C, De Bruyne B, Oldroyd K, Sakai K, Mizukami T, Collet C. Validation of virtual fractional flow reserve pullback curves. Catheter Cardiovasc Interv. 2024 Nov;104(6):1178-1188. doi: 10.1002/ccd.31222. Epub 2024 Sep 29.
- Derived from this study: PubMed 36974680Collison D, Copt S, Mizukami T, Collet C, McLaren R, Didagelos M, Aetesam-Ur-Rahman M, McCartney P, Ford TJ, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Angina After Percutaneous Coronary Intervention: Patient and Procedural Predictors. Circ Cardiovasc Interv. 2023 Apr;16(4):e012511. doi: 10.1161/CIRCINTERVENTIONS.122.012511. Epub 2023 Mar 28.
- Derived from this study: PubMed 36543445Collet C, Collison D, Mizukami T, McCartney P, Sonck J, Ford T, Munhoz D, Berry C, De Bruyne B, Oldroyd K. Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2506-2518. doi: 10.1016/j.jcin.2022.09.048. Epub 2022 Nov 30.
- 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.
Keith G Oldroyd, MB, MD principal investigator
NHS National Waiting Times Centre Board (NHS Golden Jubilee)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P.I.O.S. and Pre and post-PCI coronary physiology measurements in people with Coronary Artery Disease and Coronary Stenosis, run by NHS National Waiting Times Centre Board 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 1 inclusion and 7 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 31 Mar 2022. 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?
The proportion of patients with a final post-PCI FFR result ≥0.90 (time frame: 1 day). 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 NCT03259815, which also lists 5 linked publications.
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 31 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.