Overview

Intravenous Tenecteplase and Mechanical Thrombectomy Techniques on 4.5 to 24 Hours After Basilar Artery Occlusion

Status:
Not yet recruiting

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

Summary

Background and Rationale: Recently, two prospective multicenter RCT (ATTENTION and BAOCHE trials) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The EXTEND-IA TNK trial demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular thrombectomy for anterior circulation large vessel occlusion strokes. The COMPASS trial demonstrated the non-inferiority of functional outcomes when compared a direct aspiration as first pass thrombectomy with stent retriever first line thrombectomy in acute occlusion of anterior circulation. However, it is unclear whether intravenous tenecteplase bridging with endovascular thrombectomy is superior to endovascular thrombectomy alone in acute basilar artery occlusion and whether a direct aspiration as first pass thrombectomy is non-inferior to stent retriever first line thrombectomy in patients with basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of intravenous tenecteplase and a direct aspiration as first pass thrombectomy in these patients. Objective: 1. To assess the effect of intravenous tenecteplase plus endovascular thrombectomy compared to endovascular thrombectomy alone in patients with basilar artery occlusion (confirmed by CTA/MRA) on efficacy and safety outcomes. 2. to evaluate whether patients treated with a direct aspiration first pass (ADAPT) approach have non-inferior functional outcomes to those treated with a stent retriever as the firstline (SRFL) approach. Study design: Multicenter, prospective, controlled clinical trial with open-label treatment and blind outcome assessment (PROBE) of intravenous tenecteplase plus endovascular thrombectomy versus endovascular thrombectomy alone. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up.

Phase:

Phase 3

Details

Lead Sponsor:

The First Affiliated Hospital of University of Science and Technology of China

Treatments:

Tenecteplase