Physiology and Residual Ischemia After Percutaneous Coronary Intervention

NCT ID: NCT04494750

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2023-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quebec Heart Institute

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Olivier F. Bertrand

Director of the International Chair of Interventional Cardiology and Transradial Approach

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivier F. Bertrand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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IUCPQ - Laval Hospital

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Olivier F. Bertrand, MD, PhD

Role: CONTACT

+14186568711 ext. 5947

Facility Contacts

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Olivier F Bertrand, MD PhD

Role: primary

418 656 8711

Other Identifiers

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EASY-PRIPCI

Identifier Type: -

Identifier Source: org_study_id

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