Leader: Universitätsklinikum Heidelberg – Fatih Seker
WP2 will ensure highest quality and homogeneous standards of image assessment and endovascular treatment within the clinical trial across all participating centres. Main objectives are:
- Ensure enrollment of patients based on imaging according to the trial protocol
- Ensure safe and effective endovascular treatment of patients randomized to thrombectomy
Correct and reliable evaluation of baseline CT or MRI by trial investigators using the ASPECT score represents a key issue in order to ensure the enrolment of patients according to the trial protocol, i.e. stroke patients with extended stroke lesions reflected by an ASPECT score of 3-5. Enrolment of patients with ASPECT <6 will ensure the randomization of stroke patients with uncertain benefit of thrombectomy, while the exclusion of the very large stroke lesions with ASPECTS 0-2 will minimize the risk of symptomatic intracranial haemorrhage. Standards for image acquisition and judgement will be defined relying on established criteria (Barber et al., 2000; Barber et al., 2005). Extensive training material will be provided and a workflow for training and certification will be established.
Endovascular treatment with thrombectomy represents the active treatment arm to be tested in TENSION, and safe and effective performance of thrombectomy is a crucial factor for a successful completion of the trial. In order to ensure homogeneous highest standards of treatment across all interventionalists in all trial sites, clear and concise standards for treatment with thrombectomy in the trial will be defined according to established reference documents and standards (Fiehler et al., 2016). A workflow for training and certification of treating interventionalists will be established. Besides these procedural standards dedicated workflow descriptions for the handling of the acute stroke patients in the trial will be provided.
The WP Leader Fatih Seker is an interventional radiologist with experience in stroke imaging research and endovascular thrombectomy. Universitätsklinikum Hamburg-Eppendorf and ESMINT will support the development of training and certification material as well as the workflow of site training based on experience from previous trials (THRILL, WAKE-UP) and previous training activities provided by ESMINT. Eppdata will provide a technical solution for web-based training software.