Leader: Universitätsklinikum Heidelberg – Martin Bendszus
The main objective of WP1 is the successful completion of the clinical trial and by this to provide evidence of safety and effectiveness of endovascular thrombectomy in the population enrolled in the trial. This comprises the following component objectives:
- Design and coordinate the clinical trial
- Establish the infrastructure for successful completion of the trial
- Obtain approval of the trial in approximately 40 sites in 8 EU countries
- Enrollment of a maximum of approx. 700 patients into the clinical trial
- Ensure high quality of data and safety of patients by trial monitoring
- Provide the final study report assessing efficacy and safety of the tested treatment
TENSION will be an investigator-initiated, prospective, open label, blinded endpoint (PROBE), multinational, European, two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke (AIS) in patients with extended stroke lesions defined by an ASPECT score of 3-5 in an extended time window (up to 12 hours, or unknown time of symptom onset).
The WP Leader has a long standing experience in thrombectomy for stroke and coordination of clinical trials, e.g. the previous THRILL trial of thrombectomy in stroke with contraindications against intravenous thrombolysis (Bendszus et al., 2015). Martin Bendszus will be the coordinating investigator of TENSION, and he will be supported by Universitätsklinikum Hamburg-Eppendorf (Götz Thomalla) in establishing the trial design and infrastructure. Götz Thomalla has long standing experience in coordination of clinical stroke trials, e.g. the EU-funded WAKE-UP trial of stroke thrombolysis (Thomalla et al., 2014) and will be the neurological principal investigator of the trial. The Koordinierungszentrum Klinische Studien (KKS; Coordination Center for Clinical Trials) of the Universitätsklinikum Heidelberg will be responsible for all aspects of central trial management, supported by ECRIN in submission, on-site monitoring, local project management and local vigilance in the countries outside Austria and Germany (Czech Republic, Denmark, France (here, the activities will be carried out by Hospices Civils de Lyon), Norway (here, part of the activities will be carried out by the Oslo University Hospital), Slovak Republic, Sweden). National coordinators will support trial coordination in all participating countries (partners Medizinische Universität Innsbruck, Hradec Kralove, Aarhus University Hospital, Centre hospitalo-universitaire Reims, Oslo University Hospital, Stockholms Lans Landsting, Comenius University’s Jessenius). Before initiation of trial sites by the monitors, the clinical staff will receive training on image assessment and endovascular treatment as described in WP2 (Training and standards). Processing of brain images within the trial will be organized together with WP3 (Image core lab). Monitoring and safety management will be conducted in close cooperation with WP4 (Ethics, safety, and patient reported outcome measurement), study reports will be completed in cooperation with WP5 (Statistics).