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Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EASY-PRIPCI)

L

Laval University

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT04494750
EASY-PRIPCI

Details and patient eligibility

About

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).

Full 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.

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Olivier F. Bertrand, MD, PhD

Data sourced from clinicaltrials.gov

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