A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Summary

The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).

Conditions

• Coronary Disease
• Coronary Stenosis

Interventions

PROCEDURE

FFR guided PCI

PROCEDURE

CABG

Coronary Artery Bypass Graft Surgery (CABG)

DEVICE

Resolute Integrity Stent

Durable polymer zotarolimus-eluting stent

DEVICE

Resolute Onyx Stent

Durable polymer zotarolimus-eluting stent

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Golden Jubilee National Hospital

  collaborator OTHER_GOV

• University of California, Irvine

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Abbott Medical Devices

  collaborator INDUSTRY

• Genae

  collaborator INDUSTRY

• King's College Hospital NHS Trust

  collaborator OTHER

• Houston Methodist DeBakey Heart & Vascular Center

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• William F Fearon, MD · Stanford University

• Nico HJ Pijls, MD, PhD · Catharina Hospital Eindhoven, The Netherlands

• Bernard De Bruyne, MD, PhD · VZW Cardiovascular Research Center Aalst

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-25

Primary Completion

2020-12-01

Completion

2024-12-01

Countries

• United States
• Australia
• Belgium
• Canada
• Czechia
• Denmark
• France
• Hungary
• Lithuania
• Netherlands
• New Zealand
• Norway
• Serbia
• South Korea
• Sweden
• United Kingdom

Study Locations