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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

Must not have

Any target lesion with in-stent drug-eluting stent restenosis

Requiring renal replacement therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year, 2 years, 3 years and 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 or older with chest pain or signs of heart muscle issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My stent in a blood vessel has narrowed again.

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I need dialysis for my kidneys.

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I cannot take dual antiplatelet therapy for six months.

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I have severe heart failure requiring support.

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My heart's pumping ability is significantly reduced.

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I need surgery for a heart or other health issue, like valve replacement.

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I need a procedure to improve blood flow to my heart.

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I have had coronary artery bypass surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years, 3 years and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Death

Death, MI, or Stroke at 5 Years

Individual Components of

+7 more

Other study objectives

Myocardial infarction

Repeat revascularization

Stroke

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met