iVascular has announced that the SEMTIC study, evaluating the safety and efficacy of its comprehensive stroke thrombectomy treatment, is one step closer to providing its first outcome data, with more than 50% of patients having now been enrolled.
The primary objective of SEMTIC is to determine the safety and efficacy of three devices collectively designed and manufactured by iVascular for neurothrombectomy procedures.
The treatment combines the benefits of the company’s iNedit balloon distal access catheter and iNdeep microcatheter to facilitate placement of the iNtercept stent retriever and temporarily restrict blood flow in patients with acute ischaemic stroke caused by a large vessel occlusion (LVO).
A complete cohort of 225 patients will ultimately be enrolled across 20 sites in four countries: Spain (14 sites), Belgium (one site), Germany (three sites) and France (two sites). To date, recruitment has been completed in Spanish centres, including the Hospital Clinic de Barcelona, Hospital de Bellvitge and Hospital de la Vall d’Hebron in Barcelona; Hospital Central de Asturias in Oviedo; and Hospital Reina Sofia in Cordoba.
Principal coordinating investigator Juan Macho and co-investigator San Roman (both Hospital Clinic de Barcelona, Barcelona, Spain) said: “The recruitment is going well so far. To date, 115 patients have been recruited—all of them from centres across Spain. The first results will be reported by the beginning of 2024”.
Sara Pich, clinical affairs director at iVascular, added: “The iVascular neuro devices we assessed in SEMTIC aim to enhance patient outcomes through cutting-edge medical technology. We are totally sure that this groundbreaking study will represent a significant step forward in improving the treatment of acute ischaemic stroke.”
