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FFR-Guided PCI vs CABG for Coronary Artery Disease (FAME 3 Trial)
N/A
Waitlist Available
Led By Nico HJ Pijls, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 21 years with angina and/or evidence of myocardial ischemia
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years, 3 years and 5 years
Awards & highlights
FAME 3 Trial Summary
This trial will compare FFR-guided PCI to CABG in patients with multivessel CAD to see if there are similar outcomes.
Who is the study for?
This trial is for adults over 21 with multivessel coronary artery disease, which means they have significant blockages in all three major heart arteries but not the main left one. They must be experiencing chest pain or signs of poor blood flow to the heart and can undergo either stent placement or bypass surgery. Excluded are those with recent severe heart attacks, very weak hearts, short life expectancy, kidney failure requiring dialysis, planned organ transplants, pregnancy, or inability to take blood-thinning drugs for six months.Check my eligibility
What is being tested?
The study compares two ways to improve blood flow in patients with blocked arteries: FFR-guided PCI (a procedure where a wire measures blood pressure differences across a blockage to guide stent placement) versus traditional bypass surgery (CABG). It aims to see if using FFR measurements before placing stents results in similar health outcomes as bypass surgery.See study design
What are the potential side effects?
Possible side effects from these procedures include bleeding at the site where catheters are inserted for PCI; infection; allergic reactions to materials used; irregular heartbeat; and rarely stroke or heart attack during the procedure. Bypass surgery carries risks like wound infections and longer recovery time.
FAME 3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 or older with chest pain or signs of heart muscle issues.
FAME 3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year, 2 years, 3 years and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years, 3 years and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Death
Death, MI, or Stroke at 5 Years
Individual Components of
+12 moreOther outcome measures
Myocardial infarction
Repeat revascularization
Stroke
FAME 3 Trial Design
2Treatment groups
Active Control
Group I: FFR guided PCIActive Control3 Interventions
Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle.
Group II: CABGActive Control1 Intervention
CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels ≥ 1,5 mm in diameter and with ≥ 50% stenosis should be bypassed, if technically feasible.
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Who is running the clinical trial?
Golden Jubilee National HospitalOTHER_GOV
44 Previous Clinical Trials
10,280 Total Patients Enrolled
GenaeIndustry Sponsor
8 Previous Clinical Trials
779 Total Patients Enrolled
Catharina Ziekenhuis EindhovenOTHER
143 Previous Clinical Trials
87,496 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need dialysis for my kidneys.My stent in a blood vessel has narrowed again.I cannot take dual antiplatelet therapy for six months.You are being checked to see if you can have an organ transplant.Your blood vessels are very calcified or twisted, making it difficult to measure a specific type of blood flow.I have blockages in three major heart arteries but not the main one, treatable by surgery or stenting.I have severe heart failure requiring support.My heart's pumping ability is significantly reduced.I am 21 or older with chest pain or signs of heart muscle issues.I need surgery for a heart or other health issue, like valve replacement.I need a procedure to improve blood flow to my heart.I have had coronary artery bypass surgery.You are currently experiencing a heart attack with rising levels of cardiac troponin.I had a severe heart attack less than 5 days ago.You are expected to live less than 2 years.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: FFR guided PCI
- Group 2: CABG
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.
Where are the various sites providing this clinical trial?
"The University of Kentucky Medical Center in Lexington, Texas, Le'Centre Hospitalier de l'Universite de Montreal in Montreal, Georgia, and the University of Ottawa Heart Institute in Ottawa, California are amongst the 16 sites participating."
Answered by AI
Are new participants being accepted into this experiment currently?
"The data on clinicaltrials.gov affirms that no new participants are being sought for this trial, which was initially published in August of 2014 and last updated in December 2021. However, there are 588 other trials actively admitting patients at the present moment."
Answered by AI
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