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

## TL;DR

This study tests if adding intra-arterial tenecteplase improves reperfusion and safety in stroke patients with incomplete mechanical thrombectomy.

## Contribution

A novel randomized trial design to evaluate intra-arterial tenecteplase for residual intracranial occlusions after mechanical thrombectomy.

## Key findings

- The trial will assess early and late reperfusion outcomes using specific angiographic and perfusion criteria.
- Safety outcomes will be evaluated through standard clinical assessments at 24 hours and 90 days.

## Abstract

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.

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.

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.

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.

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.

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.

Graphical Abstract