Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct

ConditionsBasilar Artery Occlusion Ischemic Stroke Large Core Infarct

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorCapital Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.

Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.

Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.

Age ≥18 and ≤80 years.

Disqualifiers

Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.

Baseline platelet count < 50000/µL.

Baseline blood glucose of < 50mg/dL or >400mg/dL.

Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.

Trial design

Design model

Parallel

Treatments tested in this trial

Endovascular Therapy Plus Best Medical Treatment
Procedure/Surgery
Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.
Best Medical Treatment Alone
Drug
Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.

Treatment groups

314 Participants

are divided into 2 treatment groups

Group A: Endovascular Therapy Plus Best Medical TreatmentExperimental treatment 1 intervention

Group B: Best Medical Treatment AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of Patients Achieving mRS 0-3 at 90 Days

The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome.

Time frame

90 days

Secondary outcomes

Dramatic early favorable response

Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.

Time frame

24 (-2/+12) hours

Ordinal Shift analysis of mRS at 90 days

The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])

Time frame

90 days

Dichotomized mRS score (0-2 versus 3-6 )

The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])

Time frame

90 days

Proportion of Patients Achieving mRS 0-4 at 90 Days

The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])

Time frame

90 days

Other outcomes

Mortality

Time frame

90 days

Symptomatic intracranial hemorrhage

Time frame

24 (-2/+12) hours

Serious adverse events

All serious adverse events during follow-up in all randomized patients.

Time frame

90 days, 12 months, through study completion ( average of 1 year)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: