Ireland
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Active, not recruiting Not applicable

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

NCT04929496 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2021-09-10
Last updated
2025-03-19

Condition(s) studied

Coronary Artery DiseaseStable AnginaUnstable AnginaIschemic Heart DiseaseChest Pain

Investigational drug(s) / intervention(s)

post-PCI FFR

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Rate of Target Vessel Failure — within 18 months after index PCI;
    as the composite of cardiac death, lesion-related MI and target vessel revascularization
  • Rate of angina-related events — within 18 months after index PCI;
    defined as hospitalization for unstable angina and unsolicited medical visits for angina

Trial sites (1)

FacilityCityRegionStatus
IUCPQ - Laval Hospital Québec Quebec
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04929496 on ClinicalTrials.gov ↗ ← All trials in Canada