The eFACTOR Study
Research type
Research Study
Full title
Safety and performance evaluation of the ePATH Guided Percutaneous Re-entry device for guiding the delivery of a guidewire around a Chronic Total Occlusion of Lower Limb Artery for subsequent interventional procedures.
IRAS ID
274700
Contact name
Robert J Dickinson
Contact email
Sponsor organisation
Imperial College
ISRCTN Number
ISRCTN82097895
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
Patients with blockages in their leg arteries can be treated via special tubes called catheters. These catheters are inserted in the arteries and deliver wires to treat the blockage. If it is not possible to pierce the blockage then a wire is passed around the blockage by going inside the wall of the artery. Once past the blockage, the wire is redirected back into the artery (re-entry) to reconnect to the main blood stream. A channel that bypasses around the blockage is then made by inserting special tubes called grafts using the wire as a guide. Blood will then flow around the blockage through this graft back into the artery to reach the rest of the leg.
Existing devices that deliver a wire around the blockage can be difficult to use and can miss the artery. This trial is to evaluate whether new devices, the ePATH Catheter Kit and Display, which use a novel method of electronic guidance, can do this more efficiently and accurately.
The study will be performed on 10 patients from Northwick Park Hospital who need their artery unblocked and agree to participate in this research, and should take six months in total. The treatment of the blockage will remain the same as the standard treatment for the condition, except that the new ePATH devices will be used to create a channel around the blockage. The patient will not see any changes to the care given or the number of hospital visits and will leave the study after attending the usual 6 week check-up after the treatment.REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0330
Date of REC Opinion
27 May 2020
REC opinion
Further Information Favourable Opinion