Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study

Coronary Artery Disease Clinical Trial

— EASY-PREDICT  

Official title:

Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929496
• Other study ID #: EASY-PREDICT pilot study
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Laval University
• Contact: Olivier F. Bertrand, MD, PhD
• Phone: 4186568711
• Email: olivier.bertrand[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether the use of physiology parameters as guidance post-percutaneous coronary interventions (PCI) is associated with less risks of target vessel failure (TVF) and angina-related events than standard angiographic guidance.

Description:

Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximal flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value less than or equal to 0.80 is generally considered to be associated with myocardial ischemia. FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. this ratio represents the potential decrease in coronary flow distal o the coronary stenosis. Recently, other physiology ratios called non-hyperemic ratios (NHPR) have been developed. Both types of physiology measures (FFR and NHPR) have been increasingly used in cardiac catheterization laboratories as a diagnostic tool. They provide a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. However, they are underutilized as tools for the assessment of success of coronary interventions. The PREDICT study is a pilot study which aims to prospectively determine whether post-PCI physiology guidance is associated with better clinical outcomes than standard angiographic guidance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient referred for diagnostic coronary angiography and / or possible PCI in native coronary vessels.
• Successful (< 30% diameter stenosis and normal TIMI 3 flow post-stenting) and uncomplicated PCI
• All treated lesions stented with drug-eluting stents (except side-branches of bifurcations)

Exclusion Criteria:

• Lesion in saphenous vein or arterial grafts
• Allergy to aspirin, thienopyridines or ticagrelor precluding treatment for 30 days
• Sub-optimal PCI result ( >30% residual diameter stenosis and/or <TIMI3 flow) or peri-procedural complications
• Acute ST-Elevation MI (culprit lesion)

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Procedure:
• post-PCI FFR
final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.

Locations

Country	Name	City	State
Canada	IUCPQ - Laval Hospital	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	International Chair on Interventional Cardiology and Transradial Approach, Opsens Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Target Vessel Failure	as the composite of cardiac death, lesion-related MI and target vessel revascularization	within 12 months after index PCI;
Primary	Rate of angina-related events	defined as hospitalization for unstable angina and unsolicited medical visits for angina	within 12 months after index PCI;
Secondary	Final post-PCI pressure ratio values according to lesion location and intervened vessels	In the Physiology group, final pressure ratio (Pd/Pa) values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.	Post-randomization after stent implantation (< 1 hour)
Secondary	Final post-PCI FFR values according to lesion location and intervened vessels	In the Physiology group, final FFR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.	Post-randomization after stent implantation (< 1 hour)
Secondary	Final post-PCI dPR values according to lesion location and intervened vessels	In the Physiology group, final dPR values will be collected immediately after randomization, and if further intervention is performed, before completing the intervention.	Post-randomization after stent implantation (< 1 hour)
Secondary	Final post-PCI physiology pullback curves according to lesion location and intervened vessels	In the Physiology group, final physiology pullback curves will be collected immediately after randomization, and if further intervention is performed, before completing the intervention if possible.; Physiology pullback refers to either hyperemic or non-hyperemic pullback.	Post-randomization after stent implantation (< 1 hour)
Secondary	Rates of unstable angina requiring hospitalization or unsolicited medical visits		within 12 months of index procedure
Secondary	Rates of individual components of MACE	including all-cause mortality, MI, TVR and any revascularization	within 12 months of index procedure