Physiology and Residual Ischemia After Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

— EASY-PRIPCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494750
• Other study ID #: EASY-PRIPCI
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Laval University
• Contact: Olivier F. Bertrand, MD, PhD
• Phone: +14186568711
• Email: olivier.bertrand[@]chul.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	IUCPQ - Laval Hospital	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Quebec Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

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