Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

• Status: Not yet recruiting
• Trial end date: 2027-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Two recent randomized controlled trials (BAOCHE and ATTENTION) have confirmed the efficacy and safety of endovascular therapy in patient with acute ischemic stroke (AIS) due to basilar artery occlusion (BAO). However, it is still inconclusive whether there is any differences between endovascular therapy with or without bridging intravenous thrombolysis in acute BAO. So far, no randomized controlled trial has been conducted specifically for endovascular therapy with or without intravenous thrombolysis for ischemic stroke due to BAO. Therefore, this study plans to conduct a prospective, multicenter, randomized controlled trial to compare the functional outcomes between endovascular therapy with and without intravenous thrombolysis in patient with AIS due to BAO.

This study is a multicenter, parallel, open label, randomized controlled trial comparing direct endovascular therapy versus endovascular therapy bridging intravenous thrombolysis (IVT). This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6.

The main outcome is the 3-month mRS scale score. Secondary outcomes included NIHSS at 24 hours and 7 days after surgery, CTA vascular recanalization at 24-72 hours, mRS at 5-7 days, and infarct volume. The safety outcomes included 90-day mortality and the incidence of sICH.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Academy of Medical Sciences
• Collaborator: Sichuan Provincial People's Hospital
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• A clinical diagnosis of acute ischemic stroke (AIS);

• Caused by basilar artery occlusion (BAO) confirmed by CTA, MRA, or DSA;

• CT or MRI ruling out intracranial hemorrhage;

• Eligible for intravenous thrombolysis (IVT) and endovascular treatment (EVT) (within 4.5 hours after symptom onset);

• A score of at least 6 on the NIHSS score;

• Age of 18 years or older;

• Written informed consent.

Exclusion Criteria:

• Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2

• Any contra-indication for intravenous thrombolysis (IVT), according to guidelines of the American Heart Association, i.e.:

• Arterial blood pressure exceeding 185/110 mmHg

• Blood glucose less than 2.7 or over 22.2 mmol/L

• Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging

• Serious head trauma in the previous 3 months

• Major surgery or serious trauma in the previous 2 weeks

• Gastrointestinal or urinary tract hemorrhage in the previous 3 weeks

• Previous intracerebral hemorrhage

• Use of anticoagulant with INR exceeding 1.7

• Known thrombocyte count less than 100 x 10^9/L

• Treatment with direct thrombin or factor X inhibitors

• Treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.