Thrombectomy in Stroke with extended lesion and extended time window
TENSION is a European multicentre investigator-initiated randomized, controlled, prospective, open label, blinded endpoint (PROBE) trial of thrombectomy in stroke patients with extended ischemic stroke lesions including patients presenting in a late time window, who are currently excluded from available effective treatment approaches.
Stroke is a major cause of death and disability in Europe with a large social and economic impact on patients, families, and society. The burden of stroke is in large parts determined by severe strokes resulting from the occlusion of large brain-supplying arteries. About 1.5 million people suffer from stroke in the EU each year with 10-20% severe strokes that might be candidates for thrombectomy, which was proven a highly effective treatment for patients with only small stroke lesions. However, for those with already extended stroke lesions, the benefit of thrombectomy is uncertain, as these patients were usually excluded from previous clinical trials of endovascular stroke treatment.
The central objective of TENSION is to assess whether endovascular stroke treatment by thrombectomy improves clinical outcome, survival and quality of life in these patients. If the results of the trial are positive, the tested treatment could be implemented rapidly throughout Europe, would support health-equity, and would result in improved functional outcome and averted death or severe disability patients with severe stroke in Europe, as well as in a measurable reduction of costs for stroke care.