Physiology and Residual Ischemia After Percutaneous Coronary Intervention

• Conditions: Ischemic Heart Disease; Chest Pain; Coronary Restenosis; Angina Pectoris; Coronary Artery Disease

• Registration Number: NCT04494750
• Lead Sponsor: Laval University

Brief 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).

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.

Study Timeline

• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-07-31
• Study Start: 2021-02-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of successful uncomplicated PCI as per coronary physiology ratios	Transprocedural, initial and final values	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 .

Secondary Outcome Measures

Name	Time	Method
Incidence and types of further interventions or imaging techniques	Historical and immediately after the procedure, up to 36 months	Record the incidence by type of intervention and diagnostic or imaging techniques
Incidence of successful distal positioning of pressurewire	Transprocedural
Residual symptoms and quality of life after repeat angiography	up to 30 days	Identify residual symptoms after intervention, and overall immediate quality of life.
Rates of repeat interventions	Historical and immediately after the procedure	on previously intervened lesions versus PCI on new lesions

Trial Locations

Locations (1)

IUCPQ - Laval Hospital; 🇨🇦 Quebec, Canada