Request Study
Research type
Research Study
Full title
REgistry for QUality AssESsmenT with Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
IRAS ID
173697
Contact name
David Taggart
Contact email
Sponsor organisation
Medistim ASA
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
The REQUEST registry is a post marketing data collection for participants who are already scheduled to
have a heart bypass surgery. Heart surgery centres who routinely perform heart bypass surgery and who
routinely use the Medistim imaging device have been invited to participate. The study lasts from the
admission of the participant for the heart bypass surgery, up to the discharge of the participant from
hospital; this can be up to a maximum of 14 days.
Heart bypass surgery is a procedure that restores blood flow to the heart muscle by diverting the flow of
blood around a section of a blocked artery in the heart. A bypass graft, a healthy blood vessel taken from
the leg, arm, chest or abdomen, is taken and connected to the other arteries in the heart so that blood is
bypassed around the diseased or blocked area.
The Medistim device allows the surgeon to locate potential bypass vessels, evaluate their condition prior to
harvesting, and check for potential problems that can be avoided prior to chest closure. This awareness
and correction of potential problems could lead to improved patient outcomes. This registry is intended to
document surgical findings, procedural changes, and adverse events relating to the heart and brain
occurring prior to discharge.
The Medistim device provides images of the healthy vessel and shows how the blood flows through it; this
is done during the preparatory part of the surgery. The REQUEST Registry will collect information on how
the Medistim device helps the surgeon to choose the healthy bypass vessel and how he plans his surgery
based on the information provided about the bypass; if the bypass vessel is shown to be suboptimal,
information will be collected on how the surgeon changes his plan for the surgery.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0194
Date of REC Opinion
22 Apr 2015
REC opinion
Further Information Favourable Opinion