Chest Pain, Coronary Artery Disease, Ischemic Heart Disease, Stable Angina, Unstable Angina
Conditions
Keywords
Coronary Artery Disease, Fractional Flow Reserve, Post-PCI FFR, Angiography, Angioplasty
Brief 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.
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.
Interventions
PROCEDUREpost-PCI FFR
final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.
Sponsors
Opsens, Inc.
International Chair on Interventional Cardiology and Transradial Approach
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Target Vessel Failure | within 18 months after index PCI; | as the composite of cardiac death, lesion-related MI and target vessel revascularization |
| Rate of angina-related events | within 18 months after index PCI; | defined as hospitalization for unstable angina and unsolicited medical visits for angina |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final post-PCI dPR values according to lesion location and intervened vessels | Post-randomization after stent implantation (< 1 hour) | In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention. |
| Final post-PCI physiology pullback curves according to lesion location and intervened vessels | Post-randomization after stent implantation (< 1 hour) | 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. |
| Final post-PCI pressure ratio values according to lesion location and intervened vessels | 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. |
| Rates of individual components of MACE | within 18 months of index procedure | including all-cause mortality, MI, TVR and any revascularization |
| Rates of unstable angina requiring hospitalization or unsolicited medical visits | within 18 months of index procedure | — |
| Final post-PCI FFR values according to lesion location and intervened vessels | Post-randomization after stent implantation (< 1 hour) | In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention. |
Countries
Canada
Outcome results
None listed