Basilar Artery Occlusion

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.

This multicenter retrospective registry study evaluates the safety and effectiveness of endovascular therapy versus medical therapy for acute large-core basilar artery occlusion. It also investigates clinical, imaging, and laboratory factors associated with functional outcomes and mortality. Patients are grouped according to the treatment received in routine clinical practice.

Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.

Patients presenting to the emergency department with an acute ischemic stroke due to basilar artery occlusion within 24 hours of stroke onset will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase 0.25mg/kg before undergoing mechanical thrombectomy as required at treating clinician's discretion. The trial is Multi-arm, Multi-stage, prospective, randomised, open-label, blinded endpoint (PROBE) design with seamless phase 2b/3 transition if the intermediate endpoint (recanalization without symptomatic intracerebral hemorrhage) is met in analysis of the first 202 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 240 patients have completed 3 month follow-up (minimum sample size 320, maximum sample size 688).

This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.

This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.

This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.

A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.

A prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial to evaluate the safety and efficacy of endovascular mechanical thrombectomy for acute basilar artery occlusion in the extended time window

The standard therapy for acute ischemic posterior circulation stroke (PCS) often leads to poor functional outcomes and high mortality rates, despite all advances in reperfusion therapy. Recent trials have shown that adding Cerebrolysin, a cerebral neuroprotective agent, to standard therapy for patients with acute ischemic anterior circulation stroke is safe and leads to improved functional outcomes. The purpose of this study is to assess the effectiveness and safety of Cerebrolysin with standard treatment for patients with PCS secondary to basilar artery occlusion (BAO). The plan is to conduct a prospective, single-center, single-arm, open-label study with 20 acute basilar artery occlusion patients and premorbid modified Rankin Score (mRS) ≤3, treated with standard treatment (mechanical thrombectomy ± intravenous alteplase or conservative treatment) and Cerebrolysin as add-on therapy, compared with historical controls. Besides standard acute stroke assessment, standard treatment, and rehabilitation, the participants who meet the eligibility criteria will receive Cerebrolysin in a single-day dosage of 30 ml intravenously for 14 consecutive days. The participants will be closely monitored, and neuroimaging findings and clinical outcomes will be obtained during the drug administration period, on discharge, one month, and 3 months after the treatment onset. The primary endpoints are mRS (0-3) on day 90 and mortality rate 90 days after the stroke onset. The secondary endpoints are defined as a change in any type of intracerebral bleeding and a change of min. 2 points on the National Institutes of Health Stroke Scale 24 hours, 14 days, 30 days, and 90 days post-stroke. The investigators hypothesize that adding Cerebrolysin to standard stroke treatment will improve clinical outcomes and reduce morbidity and mortality in patients with acute basilar occlusion compared to standard treatment alone.

Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis. Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population . Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023). First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome. Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients . However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT. In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.