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Active, Not Recruiting

NCT Number: NCT04929496

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

post-PCI FFR

Procedure

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

Primary outcomes

  1. Rate of Target Vessel Failure

    Time frame: within 18 months after index PCI;

    as the composite of cardiac death, lesion-related MI and target vessel revascularization

  2. Rate of angina-related events

    Time frame: within 18 months after index PCI;

    defined as hospitalization for unstable angina and unsolicited medical visits for angina

Secondary outcomes

  1. Final post-PCI pressure ratio values according to lesion location and intervened vessels

    Time frame: 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.

  2. Final post-PCI FFR values according to lesion location and intervened vessels

    Time frame: 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.

  3. Final post-PCI dPR values according to lesion location and intervened vessels

    Time frame: 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.

  4. Final post-PCI physiology pullback curves according to lesion location and intervened vessels

    Time frame: 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.

  5. Rates of unstable angina requiring hospitalization or unsolicited medical visits

    Time frame: within 18 months of index procedure

  6. Rates of individual components of MACE

    Time frame: within 18 months of index procedure

    including all-cause mortality, MI, TVR and any revascularization

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • International Chair on Interventional Cardiology and Transradial Approach
  • Opsens, Inc.

Registry information

Acronym: EASY-PREDICT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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