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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chest Pain; Ischemic Heart Disease; Stable Angina; Unstable Angina
• Intervention / Treatment: Procedure: post-PCI FFR

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: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier F. Bertrand, MD, PhD; Phone Number: 5947 4186568711; Email: olivier.bertrand@fmed.ulaval.ca
• Study Contact Backup: Name: Michele Jadin; Phone Number: 4186568711; Email: michele.jadin@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Recruiting
    • IUCPQ - Laval Hospital
    • Sub-Investigator: Tomas Cieza, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Opsens, Inc.; International Chair on Interventional Cardiology and Transradial Approach
• 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): September 10, 2021
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (ACTUAL): June 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Angioplasty; Angiography; Fractional Flow Reserve; Post-PCI FFR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: EASY-PREDICT pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No