Post-PCI FFR for Coronary Artery Disease
(EASY-PREDICT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byOlivier F. Bertrand, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Laval University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

The PREDICT study is for patients undergoing diagnostic coronary angiography or PCI in native coronary vessels, who have had a successful and uncomplicated procedure with drug-eluting stents. It's not suitable for those with allergies to certain heart medications, recent acute ST-Elevation MI, or sub-optimal PCI results.

Inclusion Criteria

You are being considered for a heart test called coronary angiography or a procedure called PCI in your main heart blood vessels.

You have undergone a successful and uncomplicated procedure to open up narrowed arteries.

Any places where a drug-coated stent was used for treatment, except for certain small branches, are not allowed.

Exclusion Criteria

You have a blockage in a specific type of blood vessel called a saphenous vein or arterial graft.

You are allergic to aspirin, thienopyridines, or ticagrelor and cannot take them for at least 30 days.

You recently had a heart attack with a specific type of blockage in the heart.

+1 more

Participant Groups

This trial evaluates if using physiology parameters after PCI can reduce the risk of target vessel failure and angina-related events compared to standard angiographic guidance. The intervention being tested is post-PCI FFR (a measure of blood flow).

2Treatment groups

Experimental Treatment

Active Control

Group I: Post-PCI FFR guidanceExperimental Treatment1 Intervention

Post-PCI Fractional Flow Reserve and non-hyperemic pressure ratios measurement

Group II: Angiographical guidance onlyActive Control1 Intervention

Standard of care