Post-PCI FFR for Coronary Artery Disease

(EASY-PREDICT Trial)

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

221 Participants Needed

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.

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 data supports the effectiveness of the treatment post-PCI FFR for coronary artery disease?

Research shows that using post-PCI FFR (a measure of blood flow in the heart) can help identify problems with stents and predict long-term outcomes, suggesting it could improve the success of heart procedures. ^{1 2 3 4 5}

Is post-PCI FFR generally safe for humans?

Post-PCI procedures, including those using FFR (fractional flow reserve), are generally safe, but there can be risks like vascular complications and renal impairment. Most adverse events occur shortly after the procedure, with the risk decreasing significantly after the first few hours. ^{6 7 8 9 10}

How is the post-PCI FFR treatment different from other treatments for coronary artery disease?

Post-PCI FFR (fractional flow reserve) is unique because it is used after a stent is placed in the heart to check how well blood is flowing through the artery. This helps identify any issues with the stent or other blockages that might not be visible with standard imaging, potentially improving the long-term success of the treatment. ^{1 3 11 12 13}

Research Team

Olivier F. Bertrand, MD, PhD

Principal Investigator

International Chair on Interventional Cardiology and Transradial Approach

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.

Timeline

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

Treatment Details

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).

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Fractional Flow Reserve following Percutaneous Coronary Intervention. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Role of Postintervention Fractional Flow Reserve to Improve Procedural and Clinical Outcomes. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Impact of impaired fractional flow reserve after coronary interventions on outcomes: a systematic review and meta-analysis. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Predicting vascular complications in percutaneous coronary interventions. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Incidence, predictors and clinical implications of new renal impairment following percutaneous coronary intervention. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

QFR-Based Virtual PCI or Conventional Angiography to Guide PCI: The AQVA Trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Timing of and risk factors for myocardial ischemic events after percutaneous coronary intervention (IMPACT-II). Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse events beyond 1 year after percutaneous coronary intervention. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Prognostic Implications of Fractional Flow Reserve After Coronary Stenting: A Systematic Review and Meta-analysis. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

Machine-learning-based prediction of fractional flow reserve after percutaneous coronary intervention. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

FFR-Guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care: The FFR REACT Trial. [2022]