Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study

Study Overview
=================
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.

Official Title
-----------------
Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study

Conditions
-----------------
Coronary Artery Disease, Stable Angina, Unstable Angina, Ischemic Heart Disease, Chest Pain

Intervention / Treatment
-----------------
* Procedure: post-PCI FFR


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Angiographical guidance only<br>Standard of care | |
| Experimental: Post-PCI FFR guidance<br>Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement | Procedure: post-PCI FFR<br>* final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.<br>* Other names: Non-hyperemic pressure ratios;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Target Vessel Failure | as the composite of cardiac death, lesion-related MI and target vessel revascularization | within 12 months after index PCI; | 
| Rate of angina-related events | defined as hospitalization for unstable angina and unsolicited medical visits for angina | within 12 months after index PCI; | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 12 months of index procedure | 
| Rates of individual components of MACE | including all-cause mortality, MI, TVR and any revascularization | within 12 months of index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Fractional Flow Reserve, Post-PCI FFR, Angiography, Angioplasty