The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001, China
Location status: Recruiting
NCT Number: NCT05827042
To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Hefei, Anhui, 230001, China
Location status: Recruiting
Two recent randomized, controlled trials from China-ATTENTION (Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion) and BAOCHE (Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The DEVT (Direct Endovascular Treatment versus Standard Bridging Therapy for Acute Stroke Patients with Large Vessel Occlusion in The Anterior Circulation) and DIRECT-MT (Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Trial) trials showed that endovascular thrombectomy alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. However, it is unclear whether endovascular thrombectomy alone is noninferior to intravenous thrombolysis bridging with endovascular thrombectomy for achieving functional independence at 90 days among patients with acute basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of endovascular thrombectomy alone in these patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
Other names: Alteplase or Tenecteplase
Endovascular thrombectomy
Time frame: 90 (± 14 days) after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 (± 14 days) after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 (± 14 days) after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 (± 14 days) after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 90 (± 14 days) after procedure
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Time frame: 24 hours after procedure
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 5-7 days or discharge after procedure
The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Time frame: 90 (± 14 days) after procedure
The EQ-5D-5L is a questionnaire designed to assess five dimensions of life quality related to mobility, self-care, usual activities, pain or discomfort, and anxiety or depression (range: 0.39 to 1, with a higher score indicating a higher quality of living)
Time frame: 90 (± 14 days) after procedure
The Barthel Index is an ordinal scale for measuring performance of patients'self-care activities of daily living. Scores range from 0 to 100, with 0 indicating severe disability and 95 or 100 indicating no disability that interferes with daily activities.
Time frame: within 5 minutes at angiography
Evaluate effect of intravenous thrombolysis on reperfusion
Time frame: Within 5 minutes at final angiography of thrombectomy
Evaluate effect of thrombectomy on reperfusion
Time frame: Within 72 hours after procedure
Evaluate vascular patency after treatment
Time frame: Within 72 hours after procedure
PC-ASPECTS=10 indicates a normal scan, PC-ASPECTS=0 indicates early ischemic changes or hypoattenuation in all above territories. 1 or 2 points each are subtracted for early ischemic changes or hypoattenuation in: left or right thalamus, cerebellum or posterior cerebral artery territory, respectively (1 point); any part of midbrain or pons (2 points)
Time frame: Within 72 hours after procedure
Symptomatic intracranial hemorrhage defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, or intraventricular hemorrhage that led to death or was observed on an imaging scan obtained 24 to 72 hours after treatment, combined with a neurologic worsening of at least 4 points from baseline on the NIHSS or from the lowest NIHSS score between baseline and 24 hours, or death from any cause within 90 days.
Time frame: Within 72 hours after procedure
Evaluate intracerebral hemorrhage
Time frame: 7 (± 2 days) and 90 (± 14 days) after procedure
Evaluate death rate
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of University of Science and Technology of China
Other
Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Endovascular Thrombectomy on Acute Basilar Artery Occlusion - a Multicenter, Randomized Controlled, Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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