A Clinical Investigation to Evaluate the HYPEREM™IC catheter v1
Research type
Research Study
Full title
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.
IRAS ID
184769
Contact name
Paul Weinberger
Contact email
Sponsor organisation
Diasolve Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 4 days
Research summary
Coronary artery disease affects millions of people worldwide. It is caused by a narrowing or blocking of the arteries 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 angiograhy, while the hyperaemic agent, normally adenosine, is delivered by continuous intravenous infusion via a central femoral vein, a large peripheral cannula or intra-coronary bolus injection.
The investigational device in this investigation is a combined pressure wire and hyperaemic agent delivery catheter, which allows administration of the hyperaemic agent and a pressure wire to be delivered simultaneously into the coronary artery, when performing a FFR measurement using currently available pressure wire systems.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0372
Date of REC Opinion
17 Nov 2015
REC opinion
Further Information Favourable Opinion