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

N/A
Waitlist Available
Led By Olivier F. Bertrand, MD, PhD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 12 months after index pci;
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two methods of guiding PCI to see which is associated with less risk of TVF and angina-related events.

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Since this study focuses on procedural guidance rather than new medications, side effects are related to the usual risks of PCI procedures such as bleeding, artery damage, heart attack, kidney problems from contrast dye used during angiography.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 months of index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 months of index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Target Vessel Failure
Rate of angina-related events
Secondary study objectives
Final post-PCI FFR values according to lesion location and intervened vessels
Final post-PCI dPR values according to lesion location and intervened vessels
Blood Vessel
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Opsens MedicalUNKNOWN
3 Previous Clinical Trials
212 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
152 Patients Enrolled for Coronary Artery Disease
Opsens, Inc.Industry Sponsor
6 Previous Clinical Trials
393 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
152 Patients Enrolled for Coronary Artery Disease
Laval UniversityLead Sponsor
430 Previous Clinical Trials
178,174 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
7,170 Patients Enrolled for Coronary Artery Disease

Media Library

post-PCI FFR Clinical Trial Eligibility Overview. Trial Name: NCT04929496 — N/A
Coronary Artery Disease Research Study Groups: Angiographical guidance only, Post-PCI FFR guidance
Coronary Artery Disease Clinical Trial 2023: post-PCI FFR Highlights & Side Effects. Trial Name: NCT04929496 — N/A
post-PCI FFR 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929496 — N/A
~0 spots leftby Dec 2024
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