Safety and Efficacy of intra-arterial Tenecteplase for non-complete reperfusion of intracranial occlusion

The primary objective of this trial is to determine the **safety** and **efficacy** of intra-arterial **Tenecteplase** in patients experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion, characterized by residual occlusions after mechanical thrombectomy. This is clinically relevant as it addresses the need for effective treatment options in cases where mechanical thrombectomy alone does not achieve complete reperfusion, potentially improving patient outcomes in acute ischemic stroke management.

Secondary objectives include evaluating whether patients treated with additional intra-arterial Tenecteplase exhibit superior outcomes in terms of clinical efficacy and technical efficacy compared to the control group. This assessment is crucial for understanding the potential benefits of Tenecteplase in enhancing treatment efficacy beyond standard care.

The clinical trial involves participants diagnosed with **acute ischemic strokes** with incomplete reperfusion. The study population includes both male and female subjects aged 18 years and older. Participants are selected based on specific clinical signs consistent with an acute ischemic stroke and have undergone endovascular stroke treatment. The trial does not specify the total number of participants, as this information was not provided by the sponsor. The study population includes individuals who have experienced a large vessel occlusion in the anterior circulation and have residual occlusions after mechanical thrombectomy. The trial considers a vulnerable population, and participants must provide informed consent. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the **safety** and **efficacy** of intra-arterial **tenecteplase** in patients experiencing acute ischemic strokes with incomplete reperfusion following mechanical thrombectomy. This study is a randomized, double-blind, controlled trial, with an estimated duration from May 2023 to December 2025. Participants will be randomly assigned to receive either the investigational product or a control treatment, ensuring that neither the participants nor the investigators are aware of the group assignments to minimize bias.

The trial will commence with a screening visit to confirm eligibility based on specific inclusion criteria, such as age (≥18 years), clinical signs of acute ischemic stroke, and incomplete reperfusion as defined by specific criteria. Following successful screening, participants will be enrolled and randomized. The primary endpoint is early and late reperfusion, while secondary endpoints include the degree of disability or dependence at 90 days, changes in the National Institutes of Health Stroke Scale (NIHSS) at 24 hours and 90 days post-randomization, quality of life assessments, and all-cause mortality at 90 days.

Participants will be involved in the study for a period that includes the initial treatment and follow-up visits at specified intervals, with the final assessment occurring approximately 90 days post-randomization. Conditions that may lead to early termination from the study include withdrawal of consent, adverse events, or any situation where continued participation is deemed not in the participant's best interest by the investigator. The trial aims to provide valuable insights into the potential benefits of tenecteplase for patients with acute ischemic strokes and incomplete reperfusion.

The clinical trial involves the administration of **Tenecteplase**, marketed under the name Metalyse 10,000 units, which is provided as a **powder and solvent for solution for injection**. This experimental medication is intended for **intra-arterial use**. The pharmaceutical form is a **solution for injection**, and the active substance is derived from a protein of other origin. The maximum daily and total dose is 3 mg, with a treatment period not exceeding one day. The medication is manufactured by Boehringer Ingelheim International GmbH and is identified by the ATC code B01AD11. The primary objective of the trial is to assess the safety and efficacy of intra-arterial Tenecteplase in patients with acute ischemic stroke due to large vessel occlusion, who have incomplete reperfusion with residual occlusions following mechanical thrombectomy.

The efficacy of intra-arterial **Tenecteplase** in patients with acute ischemic stroke due to large vessel occlusion will be assessed through a series of primary and secondary endpoints. The primary endpoint focuses on early and late reperfusion, which will be evaluated to determine the effectiveness of the treatment in achieving reperfusion in patients with incomplete reperfusion after mechanical thrombectomy.

Secondary endpoints include the degree of disability or dependence at 90±15 days, assessed by the modified Rankin Scale (mRS) through a shift analysis. Additionally, the normalized change in the National Institutes of Health Stroke Scale (NIHSS) at 24±6 hours post-randomization and the change in NIHSS at 90±15 days post-randomization will be measured. Quality of life will be evaluated using the EuroQol 5D-3L at 90±15 days, and all-cause mortality at 90 days will also be recorded.