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Safety and efficacy of intra-arterial tenecteplase for non-complete reperfusion of intracranial occlusions : Methodology of a randomized, controlled, multicenter study

Title: Safety and efficacy of intra-arterial tenecteplase for non-complete reperfusion of intracranial occlusions : Methodology of a randomized, controlled, multicenter study
Authors: Kaesmacher, Johannes; Mujanovic, Adnan; Beyeler, Seraina; Bütikofer, Lukas; Beyeler, Morin; Piechowiak, Eike I.; Dobrocky, Tomas; Katan, Mira; Mordasini, Pasquale; Boulouis, Grégoire; Kulcsar, Zsolt; Psychogios, Marios; Mazighi, Mikael; Strbian, Daniel; Thomalla, Götz; Lemmens, Robin; Schäfer, Jan Hendrik; Dorn, Franziska; Jansen, Olav; Schwab, Roland; Kniep, Helge; Fiehler, Jens; Zi, Wenjie; Gralla, Jan; Fischer, Urs
Contributors: Neurologian yksikkö; Clinicum; HUS Neurocenter
Publisher Information: SAGE Publications Inc.
Publication Year: 2026
Collection: Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto
Subject Terms: intra-arterial; Reperfusion; tenecteplase; TICI; Neurology and psychiatry; General medicine; internal medicine and other clinical medicine
Description: RATIONALE: Intra-arterial fibrinolytics may be used for distal remaining vessel occlusions after incomplete mechanical thrombectomy (MT). However, their efficacy in improving reperfusion in this specific clinical scenario is unclear. While better reperfusion may lead to improved clinical outcomes, additional fibrinolytics could also increase the risk of hemorrhagic complications. AIM: To assess the safety and reperfusion efficacy of intra-arterial tenecteplase (TNK) compared to no further interventional treatment in patients with incomplete reperfusion and mechanically non-amendable residual occlusions after MT. METHODS AND DESIGN: This is an international, multicenter, randomized (1:1) controlled, two-arm, open, assessor-blinded, surrogate endpoint trial. The interventional arm receives 3 mg (not weight-adjusted) intra-arterial TNK, administered as close as possible to the residual occlusion. The control arm receives no further interventional treatment. SAMPLE SIZE: TECNO will randomize 156 participants 1:1 to 3 mg intra-arterial tenecteplase or no further interventional treatment. This sample size is based on anticipated absolute improvements in early and late reperfusion with intra-arterial TNK of 25% and 30%, respectively. OUTCOMES: The two co-primary imaging outcomes are early and late reperfusion. Early reperfusion is defined as an extended Thrombolysis in Cerebral Infarction (eTICI) score ⩾ 2a for residual occlusions on angiography 25 min after randomization. Late reperfusion is defined as the absence of a wedge-shaped perfusion delay on delay-sensitive perfusion maps assessed on 24 h ± 6 h perfusion imaging. Standard secondary clinical outcomes will be assessed at 24 h and 90 ± 15 days. DISCUSSION: The TECNO trial will provide evidence on the safety and reperfusion efficacy of locally administered intra-arterial TNK in patients with residual occlusions following MT. ; Peer reviewed
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
Relation: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The TECNO trial is funded by the Swiss National Science Foundation and Boehringer Ingelheim (Ingelheim am Rhein, Germany). The foundation and the company was not involved in protocol design, analysis, interpretation of the results or decision for publication.; https://hdl.handle.net/10138/627762; 105028999665; 001652010500001
Availability: https://hdl.handle.net/10138/627762
Rights: cc_by ; info:eu-repo/semantics/openAccess ; openAccess
Accession Number: edsbas.E6BDF546
Database: BASE