Evaluation of the effectiveness of the ePATH Guided Re-entry Catheter Kit in bypassing a blockage of a leg artery
| ISRCTN | ISRCTN82097895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82097895 |
| IRAS number | 274700 |
| Secondary identifying numbers | 19IC5677, IRAS 274700 |
- Submission date
- 11/03/2020
- Registration date
- 02/07/2020
- Last edited
- 17/01/2022
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Dept Of Bioengineering
Imperial College
Exhibition Road
London
SW7 2AZ
United Kingdom
 ORCID ID |
0000-0002-5999-7015 |
|---|---|
| Phone | +44 (0)20 7594 5662 |
| robert.dickinson@imperial.ac.uk |
Scientific
Dept Of Bioengineering
Imperial College
Exhibition Road
London
SW7 2AZ
United Kingdom
| ORCID ID |
0000-0002-5999-7015 |
|---|---|
| Phone | +44 (0)20 7594 5662 |
| robert.dickinson@imperial.ac.uk |
Study information
| Study design | Prospective non-randomised single-arm single-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | eFACTOR |
| Study objectives | To investigate whether the ePATH Catheter Kit and Display can be used to safely deliver a guidewire that bypasses a CTO. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/01/2020 |
| Completion date | 31/12/2020 |
| Reason abandoned (if study stopped) | Participant recruitment suspended and the study was ultimately closed due to public health guidance causing restrictions to study activities |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 11/03/2020 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Harrow
London
HA1 3UJ
United Kingdom
Sponsor information
University/education
Room 221
Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)2075949832 |
|---|---|
| cheuk-fung.wong@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk/joint-research-compliance-office/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed clinical journal within a year after the trial end date (in 2021) |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/01/2022: The study status has been changed to 'Stopped'. The study did not start recruitment.
29/07/2020: The ethics approval was added.
17/03/2020: Trial's existence confirmed by London - Dulwich Research Ethics Committee.
