An interventional study of Mechanical thrombectomy in Acute Ischemic Stroke and Basilar Artery Occlusion, sponsored by Capital Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
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
This trial aims to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects presenting with stroke due to basilar artery occlusion in the extended time window of 24-72 hours from symptom onset or time last seen well. In this trial, the randomization will employ a 2:1 ratio of mechanical thrombectomy versus best medical management alone. Randomization will be stratified according to age (18-70 or >70), baseline NIHSS (6-20 or >20) and therapeutic window (24-48 hours or >48 hours). For the primary endpoint, subjects will be followed for 90 days post-randomization.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 309 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical criteria
Any other condition that, in the opinion of the investigator will pose a significant hazard to the subject if participating in the trial.
Neuroimaging criteria
Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.
Procedure: Mechanical thrombectomy
Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.
Neurointerventionist 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.
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 days
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
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 90 days
Barthel Index at 90 days
An ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Time frame: 90 days
Quality of life analysis as measured by EuroQol Five Dimensions (EuroQol/EQ-5D)
EuroQol Five Dimensions (EuroQol/EQ-5D) is a well-known and widely used health status instrument, and could be used to measure, compare and value health status across disease areas.
Time frame: 90 days
Difference in proportion of patients with mRS 0-2 scores between the two groups at 12 months.
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 12 months
Difference in proportion of patients with mRS 0-3 scores between the two groups at 12 months.
The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\])
Time frame: 12 months
Proportion of basilar artery recanalization
Vessel recanalization evaluated by CT angiography (CTA), MR Angiography (MRA) or conventional angiography at 24-72 hours in both treatment groups assessed by Arterial Occlusive Lesion（AOL) grades and adjudicated by a central core-lab. Vessel recanalization post procedure in the thrombectomy arm assessed by mTICI grades. Successful recanalization is defined as mTICI (Modified Thrombolysis in Cerebral Infarction) 2b or 3 on the post-procedure angiogram.
Time frame: 24-72 hours (both treatment groups); post procedure immediately (thrombectomy arm)
Mortality
Death
Time frame: 90 days
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 hours
Serious adverse events (SAE)
All SAE during follow-up in all randomized patients.
Time frame: 90 days, 12 months, during follow-up
Plan to share: No — The study is proceeding.
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