Title: Vascular
Funder: Department of Health and Social Care

Abstract: Short term objectives (Year 1): Objective 1: to embed vascular surgery as a theme within MIC Surgical Technologies with national reach and impact. The vascular theme lead, Prof DJA Scott, will work closely with the MIC central office to develop vascular surgery as one of the 3 clinical themes. To facilitate this, strong links will be fostered with national professional associations, including our strategic partner (RCS Engl.) and its specialty societies - Vascular Society of GB and Ireland, British Society of Endovascular Therapies, Society of Academic and Research Surgery, and Association of Surgeons of GB and Ireland. The VSGBI is the national society for over 600 UK vascular surgeons, with specialist interest groups in aneurysms (thoracic and abdominal), lower limb arterial disease, diabetic foot disease and venous disease. It is the channel for communication to other national and government bodies for dissemination and policy development. We will establish a strong national identity by working closely with national associations, facilitated through joint promotion of events, contribution to newsletters, reciprocal links to websites, and representation at national meetings. We will contribute to the MIC young innovation community, bringing our collaborations with the Rouleaux Club (national society for trainee vascular surgeons) and VERN (trainees Vascular and Endovascular Research Network), and promoting engagement with the NHS Clinical Entrepreneurs Training Programme to create a dynamic national network. Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. Through our programme of networking events we will bring together partners from vascular surgery, academia, industry, and PPI to identify new areas for technological development (Innovation cycle: stage 1). We will focus on areas of strength, developing projects with the MIC supporting work streams in physics and engineering, clinical trials, health economics research, pathology, and business development and commercialisation. We will contribute to MIC PPI events, expanding our Vascular Patient Interest Group (VPIG) and linking to the MIC PPI Group and other patient charities/organisations to ensure that projects that are developed that address real unmet needs in vascular surgery. Objective 3: accelerating the pull through of early technologies into clinical practice. We will use the expertise of our supporting work streams, and extensive contacts with academia and industry, to progress projects smoothly through the innovation cycle towards commercialisation and adoption. We will contribute to the MIC Surgical Test Bed (Innovation cycle: step 3), forming consortia with other regional vascular units through VSGB&I to undertake rapid and affordable early clinical evaluation of vascular technologies. Examples of technologies to be evaluated in the Surgical Test Bed include: Vicorder device for rapid cardiovascular assessment, and Moleculight i:X (bacterial autofluorescence device for wound infection). We will facilitate the performance of clinical validation studies (Innovation cycle: step 4) through Leeds RCS STC vascular theme, with wider links to the RCS STEPS (Surgical Technologies Evaluation Portal) programme and RCS National Research Collaborative, providing expertise in clinical trials methodology, design, and evaluation and assistance in grant writing. Key deliverables: i) vascular surgery as a MIC theme with strong links to professional associations ii) networking events to identify unmet clinical needs in vascular disease, iii) Young Innovators programme linking to vascular organisations, iv) recruitment of vascular patients to the MIC Surgical Test Bed. Measures of success: i) identification of 10 unmet clinical need iii) contribution to 4 networking events and 1 MIC National meeting, iii) 4 new projects, 2 with pumppriming, iv) 100 vascular patients recruited to phase I and II clinical studies. Medium term objectives (years 2 & 3) Objective 1: growing the MIC as the premier national network for Surgical Technologies We will continue to engage with other NIHR infrastructure (Leeds Clinical Research Facility (CRF), NOCRI, other MICs) and MedTech organisations (ASHNs, Medilink, KTN) to mutual advantage. We will work with our key strategic partner (RCS Engl.) and specialist societies (VSGBI, BSET etc.) establishing national identity and engaging with the wider vascular/endovascular (British Society of Interventional Radiology, European Society of Vascular Surgery). Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. We will continue to engage with local (LIST) and national research networks (Society for Academic and Research Surgery) to encourage wider participation in the MIC. There is a particular synergy between our work as a Major Trauma Centre (3rd largest Major Trauma Centre in the UK serving a population of 3 million) and the Woundcare HTC, and we will seek to extend this to the Trauma HTC. There is an opportunity for capacity building through the NIHR academic careers programme and links to the Wellcome N4 PhD programme and the ERASMUS European research exchange programme (Innovation cycle: step 2). There are established links to other engineering and academic institutions through S Homer-Vanniasinkam (Inst. Biomed. Engineering, UoL; Prof Engineering & Surgery, UCL; University of Warwick Medical School), international links to Louisiana State University, USA, and funding streams including Heart Research UK, European Union, British Heart Foundation and Pfizer Global Inc. We will build on our links to industry to pull through new innovations, engaging with the wider network of clinicians and academics through industry show casing events. We are working closely with Vascular International to apply their lifelike vascular models for enhance training in vascular and trauma surgery (Scott). There are particularly close links with local SMEs, including Invitrocue Ltd and Dialogu Devices Lth (Homer-Vanniasinkam). We will work with the Circulation Foundation, Diabetes UK and British Heart Foundation to align technologies to identified areas of clinical and research need to ensure that our research is “patient-centered”. We will contribute to the MIC Young Innovators programme and incentivize activity through international exchange programmes with Nabil Chafke Department of Vascular Surgery, Strasbourg, and the Groupe Europèen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS). Objective 3: accelerating pull through of surgical technologies into clinical practice. We will contribute to the MIC Surgical Test Bed, linking with SMEs and multi-national companies to provide access to early clinical evaluation within the NHS (Innovation cycle: step 3). Vascular surgery is a clinical theme in the Leeds RCS STC, and we will work with national societies to develop new vascular trials and the next generation of CIs and PIs (Innovation cycle: step 4). The RCS STC has a cross-cutting theme in “Wound Care”, supporting a large RCT in vascular wound care (HTA MIDFUT: Multiple Interventions for Diabetic Foot Ulcer Treatment). Key deliverables: i) vascular MIC theme with national profile and strong links to RCS Engl., VSGBI, and BSIR, ii) generation of new technologies to areas of unmet clinical need in vascular surgery, iii) expansion of the MIC Young Innovators programme to vascular surgery, iv) recruitment of vascular patients to the MIC Surgical Test Bed. Measures of success: i) contribution to >10 networking events and 3 MIC National meetings, ii) >12 projects initiated or completed, iii) 5 new technologies evaluated, iv) >500 patients recruited to clinical trials, vi) >£2 million in external research income and >£6 million leveraged income. Long term objectives (year 4) Objective 1: consolidation of a mature MIC infrastructure Year 4 will see the vascular theme fully contributing to the MIC network, providing a pipeline of new technologies through its academic collaborations and industry partners, and contributing to the recruitment of patients to clinical efficacy and validation studies. We will use our patients and public groups, and links to professional and allied health associations, to showcase the achievements of the MIC and foster awareness of the new technologies developed and evaluated (Innovation cycle: step 5). The vascular theme will make a full contribution to the sustainability of the MIC network to ensure its viability beyond the 4-years of funding. It will be a key component of the MIC’s engagement strategy with the wider NHS and MedTech community. Key deliverables: i) mature MIC vascular theme with national reach and impact, ii) portfolio of innovative research projects, iii) a pipeline of new vascular technologies for clinical evaluation, iv) established lines of communication to vascular PPI, Professional Associations, and NHS Commissioning Groups for wider dissemination and adoption. Measures of success: i) engagement with 100 SMEs and multinational companies, ii) 20 active or completed projects, iii) 8 new technologies evaluated, iv) recruitment of >1,000 patients to clinical trials, v) > £4 million in external research income and >£10 million leveraged income.


Research activity codes: 8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: CARDIOVASCULAR