NCT04929496

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Stable Angina
• Unstable Angina
• Ischemic Heart Disease
• Chest Pain

Interventions

Type	Name	Description
PROCEDURE	post-PCI FFR	final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Timeline

• Start date: 2021-09-10
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2021-06-18
• Last updated: 2025-03-19

Locations

1 site across 1 country: Canada