An introduction to
the Hyperemic Study

Coronary artery disease affects millions of people worldwide. It is caused by a narrowing or blocking of the arteries of the heart due to plaque, which restricts blood flow and reduces the amount of oxygen to the heart. Over the past decade, fractional flow reserve (FFR) measurement has been increasingly used in cardiac catheterization laboratories, providing quantitative assessment of the functional severity of a coronary artery, allowing the cardiologist to discriminate between lesions that can cause ischemia and lesions that are physiologically insignificant. Measuring FFR determines the ratio between the maximum blood flow in a diseased or narrowed coronary artery and the maximum blood flow in a normal coronary artery.

This ratio represents the potential decrease in coronary flow distal to the coronary stenosis. The current standard methods of measuring FFR is to insert a pressure wire into the coronary artery during coronary angiography, while the hyperemic agent, normally adenosine, is delivered by continuous intravenous infusion via a central femoral vein, a large peripheral cannula or intracoronary bolus injection. The investigational device in this study is a combined pressure wire and hyperemic agent delivery catheter, which allows administration of the hyperemic agent and a pressure wire to be delivered simultaneously into the coronary artery, when performing a FFR measurement using currently available pressure wire systems.

Study Information

This is a single-blind, randomised, crossover investigation to evaluate the effectiveness, safety and feasibility of HYPEREM™IC . It will compare non-weight adjusted intracoronary (IC) adenosine infusion via HYPEREM™IC with the standard intra-venous method, in subjects with intermediate coronary artery stenosis.

Full title of the research:

A randomised crossover investigation to evaluate and compare the effectiveness, safety and feasibility of a novel dedicated Over-The-Wire FFR Infusion MicroCatheter (HYPEREM™IC) for measuring fractional flow reserve (FFR) using intra-coronary non-weight adjusted adenosine infusion with the standard intra-venous administration of adenosine, in subjects with intermediate coronary artery stenosis

Short title and version number:

A Clinical Investigation to Evaluate the HYPEREM™IC catheter v2

References:

Sponsor: DIAS-001-FFR
Database: NCT02527616
EudraCT: 2016-000388-18

Study Objectives

The primary objective is to demonstrate that use of the investigational device results in non-inferior FFR measurements compared to the current standard procedure. The secondary objectives are:

  • To demonstrate that the investigational device with the use of intracoronary adenosine infusion is a safe method of performing FFR measurements
  • To demonstrate that the investigational device achieves maximal hyperemia (i.e. increased coronary blood flow) with a reduced dose of adenosine
  • To demonstrate that the investigational device requires a shorter duration of adenosine administration to achieve maximal hyperemia.

The Investigational Device

HYPEREM™IC is a novel dedicated Over-The-Wire FFR Infusion Microcatheter. It facilitates simultaneous delivery of a pressure wire and administration of hyperemic agent directly into the coronary ostium or proximal section of a diseased artery when performing FFR using currently available pressure wire systems.

Investigator sites

LNWH NHS Trust
Northwick Park Hospital
Watford Road
Harrow, HA1 3UJ

Co-ordinating Investigator:
Dr Ahmed Elghamaz

Brighton & Sussex University Hospitals NHS Trust
Eastern Road
Brighton
BN2 5BE

Principal Investigator:
Dr Adam de Belder

Golden Jubilee National Hospital
Beardmore Street
Clydebank
Glasgow
G81 4HX

Principal Investigator:
Professor Keith Oldroyd