Physiology As Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study (EASY-PREDICT)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Quebec, Canada, G1V 4G5
- IUCPQ - Laval Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Angiographical guidance only
Standard of care
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Experimental: Post-PCI FFR guidance
Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement
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final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Target Vessel Failure
Time Frame: within 18 months after index PCI;
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as the composite of cardiac death, lesion-related MI and target vessel revascularization
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within 18 months after index PCI;
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Rate of angina-related events
Time Frame: within 18 months after index PCI;
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defined as hospitalization for unstable angina and unsolicited medical visits for angina
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within 18 months after index PCI;
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Final post-PCI pressure ratio values according to lesion location and intervened vessels
Time Frame: Post-randomization after stent implantation (< 1 hour)
|
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.
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Post-randomization after stent implantation (< 1 hour)
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Final post-PCI FFR values according to lesion location and intervened vessels
Time Frame: Post-randomization after stent implantation (< 1 hour)
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In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
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Post-randomization after stent implantation (< 1 hour)
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Final post-PCI dPR values according to lesion location and intervened vessels
Time Frame: Post-randomization after stent implantation (< 1 hour)
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In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.
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Post-randomization after stent implantation (< 1 hour)
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Final post-PCI physiology pullback curves according to lesion location and intervened vessels
Time Frame: Post-randomization after stent implantation (< 1 hour)
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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)
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Rates of unstable angina requiring hospitalization or unsolicited medical visits
Time Frame: within 18 months of index procedure
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within 18 months of index procedure
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Rates of individual components of MACE
Time Frame: within 18 months of index procedure
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including all-cause mortality, MI, TVR and any revascularization
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within 18 months of index procedure
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olivier F. Bertrand, MD, PhD, International Chair on Interventional Cardiology and Transradial Approach
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EASY-PREDICT pilot study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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