Basilar Artery Occlusion Chinese Endovascular Trial in the Extended Time Window
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCapital Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Posterior circulation acute ischemic stroke within 24-72 hours from symptom onset/last seen well (except for isolated vertigo), where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization.
Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
Age ≥18 and ≤ 80.
Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points.
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
Mechanical thrombectomy
Procedure/SurgeryNeurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Treatment groups
309 Participants
are divided into 2 treatment groupsGroup A: mechanical thrombectomy groupExperimental treatment 1 intervention
Group B: best medical management agroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Difference in proportion of patients achieving favorable outcomes (defined as mRS 0-3) at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame
90 daysSecondary outcomes
1
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) hours2
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame
90 days3
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame
90 days4
Barthel Index at 90 days
An ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Time frame
90 daysOther outcomes
1
Mortality
Death
Time frame
90 days2
Symptomatic intracranial hemorrhage
Clinically significant ICH rates at 24-72 hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic intracranial hemorrhage will be defined as per the following definition: deterioration in NIHSS score of ≥ 4 points and evidence of intraparenchymal hemorrhage type 2 in the 24 to 72 hours follow-up imaging scans.
Time frame
24-72 hours3
Serious adverse events (SAE)
All SAE during follow-up in all randomized patients.
Time frame
90 days, 12 months, during follow-upSponsors and contacts
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Source ClinicalTrials.gov