Coronary Artery DiseaseEASY-PREDICTNCT04929496
Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
A study testing post-PCI FFR in people with Coronary Artery Disease and Stable Angina, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Unstable Angina
- What is being tested?
- post-PCI FFR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
- Successful (< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
- All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)
Who cannot join
- Lesion in saphenous vein or arterial grafts
- Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
- Sub-optimal PCI result ( >30% residual diameter stenosis and/or <TIMI3 flow) or peri-procedural complications
- Acute ST-Elevation MI (culprit lesion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study
The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.
Read the detailed description
Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia.
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed.
Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions.
The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Ischemic Heart Disease, Chest Pain
- Being tested
- post-PCI FFR
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve, Post-PCI FFR, Angiography, Angioplasty
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable, Myocardial Ischemia, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-PCI FFRProcedure or surgery
Also called Fractional Flow Reserve, Non-hyperemic pressure ratios
final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.
| Study group | Role | What they receive |
|---|---|---|
| Angiographical guidance only | No intervention | Standard of care |
| Post-PCI FFR guidance | Experimental | Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement Receives: Procedure: post-PCI FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Target Vessel Failure
as the composite of cardiac death, lesion-related MI and target vessel revascularization
Measured: within 18 months after index PCI;
Rate of angina-related events
defined as hospitalization for unstable angina and unsolicited medical visits for angina
Measured: within 18 months after index PCI;
Secondary outcomes (6)
Final post-PCI pressure ratio values according to lesion location and intervened vessels
In the Physiology group, final pressure ratio (Pd/Pa) values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Measured: Post-randomization after stent implantation (< 1 hour)
Final post-PCI FFR values according to lesion location and intervened vessels
In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Measured: Post-randomization after stent implantation (< 1 hour)
Final post-PCI dPR values according to lesion location and intervened vessels
In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
Measured: Post-randomization after stent implantation (< 1 hour)
Final post-PCI physiology pullback curves according to lesion location and intervened vessels
In the Physiology group, final physiology pullback curves will be collected immediately after randomization, and if further intervention is performed, before completing the intervention if possible.
Physiology pullback refers to either hyperemic or non-hyperemic pullback.
Measured: Post-randomization after stent implantation (< 1 hour)
Rates of unstable angina requiring hospitalization or unsolicited medical visits
Measured: within 18 months of index procedure
Rates of individual components of MACE
including all-cause mortality, MI, TVR and any revascularization
Measured: within 18 months of index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start10 Sep 2021
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Opsens, Inc., International Chair on Interventional Cardiology and Transradial Approach
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F. Bertrand, MD, PhD, Principal investigator, International Chair on Interventional Cardiology and Transradial Approach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929496
- Sponsor's protocol ID
- EASY-PREDICT pilot study
- Acronym
- EASY-PREDICT
- Status last verified
- Jan 2025
- First submitted
- 31 May 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulacia Flores P, Cieza T, Ouarrak S, Ruhl A, Mengi S, De Larochelliere R, Garcia-Labbe D, Dery JP, Poulin A, Larose E, Noel B, Nguyen CM, Paradis JM, Bertrand OF. Clinical Impact of Concordant and Discordant Physiology Parameters Post-Percutaneous Coronary Intervention in the EASY-PREDICT Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3867-3875. doi: 10.1002/ccd.70266. Epub 2025 Oct 17.
PubMed 41104696Ulacia Flores P, Cieza T, Ouarrak S, Ruhl A, Mengi S, De Larochelliere R, Garcia-Labbe D, Dery JP, Poulin A, Larose E, Noel B, Nguyen CM, Paradis JM, Bertrand OF. Randomized Study Comparing Angiography Guidance With Physiology Guidance After PCI: The EASY-PREDICT Study. Circ Cardiovasc Interv. 2025 Jul;18(7):e015165. doi: 10.1161/CIRCINTERVENTIONS.125.015165. Epub 2025 May 21.
PubMed 40400236
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study
- ClinicalTrials.gov ID
- NCT04929496
- Acronym / sponsor ID
- EASY-PREDICT / EASY-PREDICT pilot study
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Ischemic Heart Disease, Chest Pain
- Keywords
- Coronary Artery Disease, Fractional Flow Reserve, Post-PCI FFR, Angiography, Angioplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Opsens, Inc., International Chair on Interventional Cardiology and Transradial Approach
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Jun 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.
The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.
Detailed description
Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia.
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed.
Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions.
The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiographical guidance only | No intervention | –Standard of care |
| Post-PCI FFR guidance | Experimental | Procedure: post-PCI FFRPost-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
- Successful (< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
- All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)
Key exclusion criteria (4 listed)
- Lesion in saphenous vein or arterial grafts
- Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
- Sub-optimal PCI result ( >30% residual diameter stenosis and/or <TIMI3 flow) or peri-procedural complications
- Acute ST-Elevation MI (culprit 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 |
|---|---|---|
| post-PCI FFRAlso: Fractional Flow Reserve, Non-hyperemic pressure ratiosfinal invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive. | Procedure or surgery | Post-PCI FFR guidance |
Primary outcome
Rate of Target Vessel Failure
Time frame: within 18 months after index PCI;
as the composite of cardiac death, lesion-related MI and target vessel revascularization
Rate of angina-related events
Time frame: within 18 months after index PCI;
defined as hospitalization for unstable angina and unsolicited medical visits for angina
6 secondary outcomes
Final post-PCI pressure ratio values according to lesion location and intervened vessels
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI FFR values according to lesion location and intervened vessels
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI dPR values according to lesion location and intervened vessels
Time frame: Post-randomization after stent implantation (< 1 hour)
Final post-PCI physiology pullback curves according to lesion location and intervened vessels
Time frame: Post-randomization after stent implantation (< 1 hour)
Rates of unstable angina requiring hospitalization or unsolicited medical visits
Time frame: within 18 months of index procedure
Rates of individual components of MACE
Time frame: within 18 months of index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 41104696Ulacia Flores P, Cieza T, Ouarrak S, Ruhl A, Mengi S, De Larochelliere R, Garcia-Labbe D, Dery JP, Poulin A, Larose E, Noel B, Nguyen CM, Paradis JM, Bertrand OF. Clinical Impact of Concordant and Discordant Physiology Parameters Post-Percutaneous Coronary Intervention in the EASY-PREDICT Study. Catheter Cardiovasc Interv. 2025 Dec;106(7):3867-3875. doi: 10.1002/ccd.70266. Epub 2025 Oct 17.
- Derived from this study: PubMed 40400236Ulacia Flores P, Cieza T, Ouarrak S, Ruhl A, Mengi S, De Larochelliere R, Garcia-Labbe D, Dery JP, Poulin A, Larose E, Noel B, Nguyen CM, Paradis JM, Bertrand OF. Randomized Study Comparing Angiography Guidance With Physiology Guidance After PCI: The EASY-PREDICT Study. Circ Cardiovasc Interv. 2025 Jul;18(7):e015165. doi: 10.1161/CIRCINTERVENTIONS.125.015165. Epub 2025 May 21.
- 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.
Olivier F. Bertrand, MD, PhD principal investigator
International Chair on Interventional Cardiology and Transradial Approach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-PCI FFR in people with Coronary Artery Disease and Stable Angina, run by Laval University at 1 site in Canada.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Target Vessel Failure (time frame: within 18 months after index PCI;). The study lists 2 primary outcomes in all. 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 NCT04929496, which also lists 2 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 19 Mar 2025.