Study of Intra-arterial Tenecteplase with Mechanical Thrombectomy for Treating Acute Ischemic Stroke in Adults

What this Trial Is About

Researchers are studying the safety and effectiveness of intra-arterial Tenecteplase TNK as an additional treatment in adults with acute ischemic stroke caused by large vessel blockages in the anterior circulation of the brain Internal Carotid Artery and Middle Cerebral Arteries M1 and M2 segments. This Phase 2 and 3 trial focuses on patients who have undergone mechanical thrombectomy using FDA-approved devices and achieved successful reperfusion mTICI 2b or higher. The goal is to see if adding TNK improves recovery outcomes after stroke. Participants will be randomly assigned to receive either intra-arterial TNK following their mechanical thrombectomy or the best medical care without TNK. The study compares these two approaches to evaluate treatment benefits and risks. This trial will enroll adults aged 18 to 85 years who meet specific clinical and imaging criteria related to their stroke and thrombectomy results. During the study, patients will be monitored closely with assessments including the Modified Rankin Scale mRS at 90 days to measure disability, along with safety checks such as monitoring for brain hemorrhage and neurological worsening within 24 hours after treatment. Additional outcomes like functional independence, mortality rates, revascularization grades, and infarct volume will also be tracked. The total follow-up period includes visits up to 90 days after treatment to evaluate both efficacy and safety.

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial