Post-PCI FFR for Coronary Artery Disease

(EASY-PREDICT Trial)

Not currently recruiting at 1 trial location

Overseen By Michele Jadin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Aspirin, Thienopyridines, Ticagrelor

Disqualifiers: Lesion in grafts, Acute MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-randomization

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to guide heart procedures for individuals with coronary artery disease. Researchers aim to determine if using a specific measurement called post-PCI FFR (Fractional Flow Reserve), which assesses blood flow in the heart after stent placement, can reduce the risk of future heart problems compared to the usual method. Participants will receive either standard care or this new FFR-guided approach. Individuals who have undergone a successful stent procedure without complications and have drug-eluting stents (stents that release medication) may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart procedure outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an allergy to aspirin, thienopyridines, or ticagrelor, you cannot participate.

What prior data suggests that post-PCI FFR is safe for coronary artery disease patients?

Research has shown that using post-PCI FFR (a test to measure blood flow in the heart) to guide treatment after a heart procedure is generally safe. One study found that this method can help predict the risk of problems with the treated blood vessels. Another study found that patients whose procedures were guided by FFR experienced fewer serious issues, such as heart attacks, over five years. These findings suggest that using post-PCI FFR is well-tolerated and could lead to better outcomes for people with coronary artery disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about post-PCI FFR guidance because it offers a more precise way to assess coronary artery disease after a stent procedure. Unlike the standard angiographical guidance, which mainly relies on visual inspection, this method uses Fractional Flow Reserve (FFR) and non-hyperemic pressure ratios to measure blood flow and pressure in the coronary arteries. This allows doctors to make more informed decisions about the need for additional interventions, potentially leading to better outcomes for patients.

What evidence suggests that post-PCI FFR guidance is effective for reducing target vessel failure and angina-related events?

Research has shown that using post-PCI FFR (Fractional Flow Reserve) guidance after heart procedures can improve patient outcomes. In this trial, some participants will receive post-PCI FFR guidance, which involves measuring Fractional Flow Reserve and non-hyperemic pressure ratios. One study found that post-PCI FFR can independently predict patient recovery, helping to foresee the procedure's success. Another study identified specific FFR measurements that indicate a lower risk of issues with the treated blood vessel within two years. Additionally, a low post-PCI FFR is linked to higher health risks, underscoring its importance in evaluating recovery after surgery. Overall, post-PCI FFR guidance holds promise for enhancing patient outcomes after heart procedures. ^{1 6 7 8 9}

Who Is on the Research Team?

Olivier F. Bertrand, MD, PhD

Principal Investigator

International Chair on Interventional Cardiology and Transradial Approach

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous coronary interventions (PCI) with either standard angiographic guidance or post-PCI physiology guidance

Immediate post-randomization

1 visit (in-person)

Follow-up

Participants are monitored for target vessel failure and angina-related events

18 months

What Are the Treatments Tested in This Trial?

Interventions

• post-PCI FFR

Trial Overview 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).

How Is the Trial Designed?

Group I: Post-PCI FFR guidance Experimental Treatment 1 Intervention

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

Group II: Angiographical guidance only Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Opsens Medical

Collaborator

Trials

4

Recruited

430+

Opsens, Inc.

Industry Sponsor

Trials

7

Recruited

610+

International Chair on Interventional Cardiology and Transradial Approach

Collaborator

Trials

2

Recruited

280+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6503473/

Long-term outcomes after fractional flow reserve-guided ... To explore the safety and efficacy of FFR-guided percutaneous coronary intervention (PCI) in vessels with severe diameter stenosis.

2. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.124.040969

Correlation and Relative Prognostic Power of Post– ... Post‐PCI QFR has a poor correlation with and overestimates post‐PCI FFR. Whereas post‐PCI FFR is an independent predictor of clinical outcome, post‐PCI QFR is ...

3. jacc.org jacc.org/doi/10.1016/j.jcin.2018.08.020

Predicting Outcomes After Percutaneous Coronary ... The best cutoff values for post-PCI FFR was 0.84 and for %FFR change was 15%, both of which were equally predictive of target vessel failure at 2 years.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823011998

Impact of Post-PCI FFR Stratified by Coronary Artery This study sought to assess the predictive capacity of post-PCI FFR for target vessel failure (TVF) stratified by coronary artery.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2796612

Prognostic Implications of Fractional Flow Reserve After ... In this systematic review and individual patient-level meta-analysis, low post-PCI FFR was common and demonstrated a significant and inverse association with ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.122.012542

Prognostic Value of Measuring Fractional Flow Reserve ... Post-PCI FFR measurement was a significant predictor of TVF on a vessel and patient level and an independent predictor of outcomes in a population with complex ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820232

Angiographic Findings and Post-PCI Fractional Flow Reserve Low post-PCI FFR is associated with outcomes in patients with coronary artery disease. The association between the physiologic result after PCI ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352906725001095

Association between post-PCI vessel fractional flow ... Reduced post-PCI fractional flow reserve (FFR) and suboptimal optical coherence tomography (OCT) findings are associated with impaired outcomes.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1803538

Five-Year Outcomes with PCI Guided by Fractional Flow ... An initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent ...