EASY-PRIPCI: Physiology and Residual Ischemia After Percutaneous Coronary Intervention

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04494750

Collaborator

Quebec Heart Institute (Other)

260

Enrollment

Location

33.4

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Angina Pectoris Chest Pain Coronary Artery Disease Coronary Restenosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

260 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

Official Title:

Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)

Actual Study Start Date :

Feb 18, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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

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
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
Incidence of successful distal positioning of pressurewire [Transprocedural]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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