Clinical trial NCT04929496: Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
Official title: Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: the PREDICT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Stable Angina
Unstable Angina
Ischemic Heart Disease
Chest Pain
Keywords: Coronary Artery Disease
Fractional Flow Reserve
Post-PCI FFR
Angiography
Angioplasty
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Opsens, Inc.
name: International Chair on Interventional Cardiology and Transradial Approach
First posted: 2021-06-18
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Target Vessel Failure
timeFrame: within 18 months after index PCI;
measure: Rate of angina-related events
timeFrame: within 18 months after index PCI;
Secondary outcomes:
measure: Final post-PCI pressure ratio values according to lesion location and intervened vessels
timeFrame: Post-randomization after stent implantation (< 1 hour)
measure: Final post-PCI FFR values according to lesion location and intervened vessels
timeFrame: Post-randomization after stent implantation (< 1 hour)
measure: Final post-PCI dPR values according to lesion location and intervened vessels
timeFrame: Post-randomization after stent implantation (< 1 hour)
measure: Final post-PCI physiology pullback curves according to lesion location and intervened vessels
timeFrame: Post-randomization after stent implantation (< 1 hour)
measure: Rates of unstable angina requiring hospitalization or unsolicited medical visits
timeFrame: within 18 months of index procedure
measure: Rates of individual components of MACE
timeFrame: within 18 months of index procedure
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ - Laval Hospital
Study officials:
affiliation: International Chair on Interventional Cardiology and Transradial Approach
name: Olivier F. Bertrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: