Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Opsens, Inc. | INDUSTRY |
| International Chair on Interventional Cardiology and Transradial Approach | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiographical guidance only | No Intervention | Standard of care | |
| Post-PCI FFR guidance | Experimental | Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post-PCI FFR | Procedure | final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Target Vessel Failure | as the composite of cardiac death, lesion-related MI and target vessel revascularization | within 18 months after index PCI; |
| Rate of angina-related events | defined as hospitalization for unstable angina and unsolicited medical visits for angina | within 18 months after index PCI; |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-randomization after stent implantation (< 1 hour) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olivier F. Bertrand, MD, PhD | International Chair on Interventional Cardiology and Transradial Approach | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUCPQ - Laval Hospital | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41104696 | Derived | 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. | |
| 40400236 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D017202 | Myocardial Ischemia |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 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. | 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. | Post-randomization after stent implantation (< 1 hour) |
| Rates of unstable angina requiring hospitalization or unsolicited medical visits | within 18 months of index procedure |
| Rates of individual components of MACE | including all-cause mortality, MI, TVR and any revascularization | within 18 months of index procedure |
| Derived |
| 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. 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |