CClinicalTrials.gg
Status unknownNCT04494750EASY-PRIPCIUpdated Jan 31, 2022

Physiology and Residual Ischemia After Percutaneous Coronary Intervention

An observational study in Ischemic Heart Disease, Angina Pectoris and Chest Pain, sponsored by Laval University. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Laval University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
260
Ages
18 Years and older
Sex
All
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Study summary

Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).

Read the detailed description

Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.

Assessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.

Hypothesis:

Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic result.

The use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.

02

Conditions studied

  • Ischemic Heart Disease
  • Angina Pectoris
  • Chest Pain
  • Coronary Artery Disease
  • Coronary Restenosis

Keywords

  • Coronary Artery Disease
  • Fractional Flow Reserve (FFR)
  • Coronary physiology
  • Repeat intervention
  • diastolic pressure ratio (dPR)
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 260 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients returning to the Quebec Heart Institute for a diagnostic angiography and possible PCI within 12 months of a previous uncomplicated PCI with stent implantation.

Inclusion criteria

  • Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.

Exclusion criteria

Exclusion Criteria:

  • Unable to understand study design or objectives of study.
  • Unable to sign informed consent.
  • Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)
  • Inability to comply with the study follow-up
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Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
260 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Rate of successful uncomplicated PCI as per coronary physiology ratios

    Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .

    Time frame: Transprocedural, initial and final values

Secondary outcomes

  1. Incidence and types of further interventions or imaging techniques

    Record the incidence by type of intervention and diagnostic or imaging techniques

    Time frame: Historical and immediately after the procedure, up to 36 months

  2. Residual symptoms and quality of life after repeat angiography

    Identify residual symptoms after intervention, and overall immediate quality of life.

    Time frame: up to 30 days

  3. Rates of repeat interventions

    on previously intervened lesions versus PCI on new lesions

    Time frame: Historical and immediately after the procedure

  4. Incidence of successful distal positioning of pressurewire

    Time frame: Transprocedural

07

Study locations

1 of 1 sites recruiting
  • IUCPQ - Laval Hospital
    Quebec, G1V 4G5, Canada
    • Olivier F Bertrand, MD PhD · Contact · olivier.bertrand@crhl.ulaval.ca · 418 656 8711
    • Olivier F Bertrand, MD PhD · Principal investigator
    • Tomas Cieza, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04494750
Lead sponsor
Laval University
Collaborators
Quebec Heart Institute
Responsible party
Olivier F. Bertrand (Director of the International Chair of Interventional Cardiology and Transradial Approach, Laval University) — Principal investigator
First posted
Jul 31, 2020
Start date
Feb 18, 2021
Primary completion
Oct 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Jan 31, 2022

Study contacts

Olivier F. Bertrand, MD, PhD
Contact
olivier.bertrand@chul.ulaval.ca
+14186568711 ext. 5947
Olivier F. Bertrand, MD, PhD
principal investigator · Laval University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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