Condition category
Circulatory System
Date applied
11/03/2020
Date assigned
02/07/2020
Last edited
29/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Patients who have no blood flow in their leg arteries because they are blocked can be treated via special tubes called catheters that can be inserted into the artery. First an attempt is made to pierce the blockage with a sharp wire that goes inside the catheter. If this is not possible then a wire is passed around the blockage by going inside the wall of the artery. Once past the blockage, the wire needs then to be redirected back into the downstream artery in order to reconnect to the main blood stream, a channel for blood flow that bypasses around the blockage can be made by implanting special tubes called grafts using the wire as a guide. Then blood will flow around the blockage back into the artery to reach the rest of the leg, and solve the problems caused by the blockage. One step in this process, the re-entry of the initial wire back into the vessel past the blockage, can sometimes be extremely challenging. The existing devices to achieve this re-entry can be difficult to use and can miss the artery. The aim of this study is to evaluate a new device, the ePATH Catheter Kit, which incorporates a new method of electronic guidance to assist the doctor to do this more efficiently and accurately.

Who can participate?
Patients aged 18 to 90 who have an artery that needs unblocking (chronic total occlusion of the femoral, popliteal, external iliac or common iliac suitable for endovascular intervention [PTA or peripheral stenting])

What does the study involve?
The treatment will follow the usual course, except the new ePATH Catheter Kit will be used to create a channel around the blockage instead of the existing devices. Once this is done the device will be removed and the treatment will continue unchanged, and the same graft will be implanted as before. The study will be carried out on 10 patients at Northwick Park Hospital in the second part of 2020 by the same doctor who normally carries out this treatment, the patient will not see any change to the care given or the number of hospital visits. The patient will attend the usual 6-week check-up after the treatment and leave the study at that point.

What are the possible benefits and risks of participating?
The potential benefit of this new approach is that the positioning of the wire around the blockage will be quicker, and less likely to miss the artery requiring re-positioning. There is a risk that the new ePATH Catheter Kit will not be any better at positioning the wire, if that happens then an existing device will be used. The new catheter has been thoroughly tested in the factory, but this is the first time it is used in patients which is why it is being used in a carefully observed study.

Where is the study run from?
Northwick Park Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2020 to December 2020

Who is funding the study?
National Institute of Health Research (NIHR) (UK)

Who is the main contact?
Dr Robert Dickinson
robert.dickinson@imperial.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Robert Dickinson

ORCID ID

http://orcid.org/0000-0002-5999-7015

Contact details

Dept Of Bioengineering
Imperial College
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 5662
robert.dickinson@imperial.ac.uk

Type

Scientific

Additional contact

Dr Robert Dickinson

ORCID ID

http://orcid.org/0000-0002-5999-7015

Contact details

Dept Of Bioengineering
Imperial College
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 5662
robert.dickinson@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19IC5677, IRAS 274700

Study information

Scientific 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

Acronym

eFACTOR

Study hypothesis

To investigate whether the ePATH Catheter Kit and Display can be used to safely deliver a guidewire that bypasses a CTO.

Ethics approval

Approved 21/05/2020, London - Dulwich Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road. London SE1 6LH, UK; +44 (0)207 104 8241; dulwich.rec@hra.nhs.uk), REC ref: 20/LO/0330

Study design

Prospective non-randomised single-arm single-centre observational study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Vascular disease

Intervention

Percutaneous bypass of Chronic Total Occlusions in arteries of the leg. This involves placing a guidewire around a chronic total occlusion via the sub-intimal space and back into the artery under the electronic guidance of the ePATH system. Subsequently, a graft is delivered over the guidewire and deployed to create a channel for blood perfusion to the distal vasculature. Follow up for 6 weeks.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

Measured immediately after the procedure:
1. Incidence of peri-procedural Major Adverse Events
2. Success rate of target lesion crossing defined by crossing with a 0.014 inches guide wire from true lumen to true lumen

Secondary outcome measures

Measured immediately after the procedure with the exception of late adverse events:
1. Number of deployment attempts until the guidewire enters true lumen
2. Distance between the distal cap and the re-entry point (using X-ray image post procedure and target catheter tip length as reference)
3. Time from first steps taken to insert the ePATH target catheter into vessel until successful lesion crossing, documented using fluoroscopic images/video timestamps
4, Incidence of late adverse events reported at 6-week follow-up

Overall trial start date

01/01/2020

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patient has a chronic total occlusion of the femoral, popliteal, external iliac or common iliac requiring treatment
2. Male or female patient, aged ≥18 and ≤90 years at time of enrolment
3. Suitable for endovascular intervention (PTA or peripheral stenting)
4. Able and willing to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Any of the following blood disorders, confirmed by the pre-assessment laboratory tests taken as standard of care, within the month before the procedure:
1.1. Anaemia with haemoglobin < 80g/L
1.2. Thrombopaenia with platelets ≤ 50 000/mL
1.3. Coagulation disorder with INR ≥ 1.5
2. If female, patient is pregnant or lactating at the time of enrolment or planning to become pregnant during the study time period
3. Patient has participated in another clinical study involving an investigational drug or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an investigational drug or investigational device during the course of this study. Patients enrolled in observational registries not involving investigational drug or investigational device may still be eligible
4. Patient is in custody or an institution
5. Patient has close affiliation with the study site or sponsor (e.g. employee, close relative of an employee)

Recruitment start date

11/03/2020

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northwick Park Hospital
LNWH NHS Trust Watford Road Harrow
London
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Room 221
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)2075949832
cheuk-fung.wong@imperial.ac.uk

Sponsor type

University/education

Website

https://www.imperial.ac.uk/joint-research-compliance-office/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed clinical journal within a year after the trial end date (in 2021)

IPD sharing statement
Patient identifiable data will be restricted to the study site, Northwick Park Hospital, and will be in hard copy form. Patients will be asked to consent to their data being used for this study. Requests for access to the datasets should be made to Simon Lewis, Research Governance Manager LNWH NHS Trust, R&D Office, Northwick Park Hospital, Watford Road, Harrow HA1 3UJ, Tel: +44 (0)20 8869 5173, email: simon.lewis4@nhs.net. Anonymised data and summarised data will be made available to the Chief Investigator Dr R J Dickinson, Imperial College.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/07/2020: The ethics approval was added. 17/03/2020: Trial's existence confirmed by London - Dulwich Research Ethics Committee.