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

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04929496

Collaborator

Opsens Medical (Other), International Chair on Interventional Cardiology and Transradial Approach (Other)

220

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Stable Angina Unstable Angina Ischemic Heart Disease Chest Pain	Procedure: post-PCI FFR	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 10, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Angiographical guidance only

Standard of care

Experimental: Post-PCI FFR guidance

Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement

Procedure: post-PCI FFR

final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Other Names:

Fractional Flow Reserve

Non-hyperemic pressure ratios

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Rates of unstable angina requiring hospitalization or unsolicited medical visits [within 12 months of index procedure]
Rates of individual components of MACE [within 12 months of index procedure]
including all-cause mortality, MI, TVR and any revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)