Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation

Summary

Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But patients may have more than one narrowing and studies have shown that not all narrowings need to be treated. To identify the narrowings that need treating cardiologists sometimes quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the pressure in the aorta to the pressure downstream of the narrowing).This technique requires the administration of drugs that add cost and time to the procedure and in some countries are simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR its use is limited to less than 5% of procedure. We have developed a new technique called the instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its accurate assessment. It has been approved for use in this indication. This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.

Conditions

• Coronary Artery Disease

Interventions

DEVICE

iFR

Treatment guided by instantaneous wave-free ratio

DEVICE

FFR

Treatment guided by Fractional Flow Reserve

Sponsors & Collaborators

• Imperial College London

  lead OTHER

Principal Investigators

• Justin ER Davies, MD · Imperial College London

• Javier Escaned, MD · Clinico San Carlos

• Patrick Serruys, MD · Imperial College London

• Manesh Patel, MD · Duke University

• Sayan Sen, MD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2021-01-19

Completion

2021-01-19

Countries

• United States
• Australia
• Belgium
• Egypt
• Finland
• Germany
• Italy
• Japan
• Latvia
• Netherlands
• Portugal
• Saudi Arabia
• South Africa
• South Korea
• Spain
• Turkey (Türkiye)
• United Kingdom

Study Locations