Title: Improving outcomes for hemodialysis patients through minimally invasive vascular access creation.
Funder: Department of Health and Social Care

Abstract: The project consists of four main phases or work packages (WP s), as indicated in the project plan attached, plus three background activities. Each has an associated milestone and set of deliverables. WP1 is the detailed design of devices suitable for clinical use. The optimum electrode configuration will be established and the catheter design completed. The graft and its delivery system will be selected and procured. Milestone 1 is design freeze. It is planned for 9 months from project start (end of Q2 2016). The deliverables are:- 1.1 Optimised electrode configuration 1.2 Fully documented design of the catheter and alignment system with drawings, build sheets, production test procedures. 1.3 A documented procedure on how to align and deliver the graft. 1.4 Initial risk analysis WP2 is the validation of the device designed in WP1. A technical file will be assembled to demonstrate compliance to the Medical Device Directive, including preparing an Annex 1 check list and a risk management file. A batch of sample devices will be fabricated and sent for validation testing by external bodies, the main tests required are biocompatibility, packaging, (ETO) sterility validation, electrical safety and electromagnetic compatibility. Milestone 2 is completed validation reports. It is planned for 18 months from project start (end Q1 2017). The deliverables are:- 2.1 Device Subcontract manufacturer identified 2.2 Batch of sample devices for validation manufactured by subcontractor 2.3 Full set of Technical File validation reports WP3 is the preparation for the clinical trial. This clinical trial protocol will be developed in this phase and ethics committee approval obtained. The WP2 technical file reports and documents will be submitted to the MHRA for permission to perform clinical trials. A batch of sterile devices will be manufactured for use in clinical trials. Milestone 3 is MHRA approval and is planned for 21 months into the project (end Q2 2017). The deliverables are :- 3.1 Clinical trial batch produced. 3.2 Ethic committee and MHRA submissions 3.3 MHRA approval WP4 is implementation of the clinical trial, including patient recruitment, carrying out the clinical trial, and writing the clinical trial report. On the basis of the clinical trial an application for CE marking the device can be made. Milestone 4 is completion of the clinical trial report and is planned for the project end at 36 months (end Q3 2018). The deliverables are :- 4.1 All patients recruited and procedures complete 4.2 Clinical trial report after post procedure follow-up 4.2 CE mark approved to apply to the device. WP5 is the management of IP, foreign filings of the original UK filing will be made via the PCT and then the National Phase (US and Europe) route. A US method patent will be prosecuted through to granting and a new patent filed. Milestone 5 is the completion of the National Phase applications, due 18 months into the project (end Q1 2017). The deliverables are :-. 5.1 PCT application made 5.2 National Phase application 5.3 US method patent grant 5.4 New patent filing WP6 is the management of the patient and public involvement. Steering groups and advisory groups will be set up. Milestone 6 is the convening of the first advisory Group and is scheduled 9 months into the project (end Q2 2016) and the deliverables are : 6.1 1st Steering group meeting 6.2 1st Advisory group meeting WP7 is the business development, and includes preparation of a business plan which is the milestone 30 months into the project (end Q4 2017), this is the main deliverable. WP8 is project management, and there are no specific deliverables or milestones.

Lay abstract: There are more than two and half million people world wide with kidney conditions who receive long term (sometimes life-long) dialysis treatment, which involves the external filtering of their blood by specialist equipment. This well established treatment, often requires a number of dialysis sessions a week, and involves the routine accessing of the patient s blood vessels. As a consequence of this long-term need, patients are required to undergo a pre-treatment procedure to create a so-called vascular access site. This allows the dialysis equipment to connect to a blood vessel with good blood flow and pressure, both needed to facilitate effective treatment. Creating these vascular access sites involves invasive surgery and a skilled surgical team to connect an artery and vein in the patients arm to create what is medically referred to as a fistula. Although these procedures are well established, creating good quality, long-term vascular access sites in patients is a major issue with more than 85% of sites failing during treatment. Since a patient cannot receive dialysis if their fistula has failed, this represents a serious risk to the patient s life and, at minimum, stress for the patients and families. Additionally, dealing with such failures through additional surgery represents a significant burden on healthcare providers, estimated at $4.6 billion annually in the USA alone. Stent Tek Limited, in partnership with Imperial College London and the Imperial College Healthcare NHS Trust, has devised a novel approach to creating fistulas in patients which will be: More reliable and less prone to failure Created using a minimally invasive procedure, eliminating post-surgery complications Easier to quicker to create, reducing risk for the patient The novel approach devised by Stent Tek Limited builds on proof-of-concept research undertaken at Imperial College London and is based on creating a fistula using a synthetic connector tube (known as a stent), which is inserted in to the patient via small needle size punctures. The process would be facilitated by the use of a guidance tool, which would allow the clinician to guide the stent to connect an artery to the adjacent vein to create the fistula. The approach brings together existing technologies coupled together with an innovative guidance tool. The i4i grant is required to further develop the prototype and manufacture a number of devices for use in clinical trials. The development process will involve input from specialist clinicians and dialysis patients, alongside computer aided design and modelling, to ensure that the design is effective, easy to use and safe for patients. In summary, it is believed that the development of a minimally invasive approach to vascular access for patients needing dialysis treatment will represent a major improvement to the quality of life for both patients and their families and at the same time significantly reduce costs for the healthcare system.

Research activity codes: 5.4 SURGERY
Health categories: RENAL AND UROGENITAL