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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
EASY-PREDICT Trial Summary
This trial will compare two methods of guiding PCI to see which is associated with less risk of TVF and angina-related events.
Eligible Conditions
- Coronary Artery Disease
- Chest Pain
- Stable Angina
- Angina
EASY-PREDICT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 12 months of index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 months of index procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Target Vessel Failure
Rate of angina-related events
Secondary outcome measures
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
+3 moreEASY-PREDICT 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
417 Previous Clinical Trials
172,052 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
7,170 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You had a poor result from a previous heart procedure or had complications during the procedure.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.
Research Study Groups:
This trial has the following groups:- Group 1: Angiographical guidance only
- Group 2: Post-PCI FFR guidance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaged in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov shows the initiation of this trial on September 10th 2021 and a recent update made to it at the end of January 2022. At present, 220 participants are required from 1 site for successful recruitment."
Answered by AI
Is participation in this experiment currently open to individuals?
"Clinicaltrials.gov states that this clinical trial is currently open for enrollment, with the initial posting taking place on September 10th 2021 and an update being posted on January 28th 2022."
Answered by AI
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