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

L

Laval University

Status

Enrolling

Conditions

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

Treatments

Procedure: post-PCI FFR

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04929496
EASY-PREDICT pilot study

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

220 participants in 2 patient groups

Angiographical guidance only
No Intervention group
Description:
Standard of care
Post-PCI FFR guidance
Experimental group
Description:
Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement
Treatment:
Procedure: post-PCI FFR

Trial contacts and locations

0

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Central trial contact

Olivier F. Bertrand, MD, PhD; Michele Jadin

Data sourced from clinicaltrials.gov

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