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Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

Primary Purpose

Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Intravenous thrombolysis
Endovascular thrombectomy
Sponsored by
The First Affiliated Hospital of University of Science and Technology of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basilar Artery Occlusion focused on measuring Thrombectomy, thrombolysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery; Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion; Patient's age ≥ 18 years; Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery; Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria; Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10; The patient or patient's legal representative signs the informed consent form. Exclusion Criteria: CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds is allowed); Pre-stroke modified Rankin scale (mRS) score ≥ 2; Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) <5; Pregnant or lactating women; Allergy to contrast agent or nitinol alloy; Life expectancy<1 year; CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment; Participating in other clinical trials; Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, which can not be controlled by antihypertensive drugs; Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) > 1.7; or novel oral anticoagulant within prior 48 hours; Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L), platelet< 100*109/L; Renal insufficiency defined as serum creatinine >2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate <30 mL/min, need for hemodialysis or peritoneal dialysis; Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc); The patient has acute ischemic cerebral infarction within 3 months from randomization; The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis; The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition; CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle; Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination; CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion; Patients with intracranial tumors (except small meningiomas); Patients who received intravenous thrombolytics treatment before the randomization.

Sites / Locations

  • The First Affiliated Hospital of University of Science and Technology of ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovascular thrombectomy alone

Intravenous thrombolysis plus endovascular thrombectomy

Arm Description

Patients will receive endovascular thrombectomy without intravenous thrombolysis.

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Outcomes

Primary Outcome Measures

Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

Secondary Outcome Measures

Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days)
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days)
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 days)
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days)
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Score on the National Institute of Health Stroke Scale (NIHSS) at 24 hours
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.
Score on the NIHSS at 5-7 days or discharge
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.
Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days)
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)
level of activities of daily living (Barthel index, BI) at 90 days (±14 days)
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.
Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy
Evaluate effect of intravenous thrombolysis on reperfusion
Successful reperfusion on final angiography of thrombectomy
Evaluate effect of thrombectomy on reperfusion
Successful recanalization on CT or MR angiography within 72 hours
Evaluate vascular patency after treatment
Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours
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)

Full Information

First Posted
April 12, 2023
Last Updated
August 15, 2023
Sponsor
The First Affiliated Hospital of University of Science and Technology of China
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1. Study Identification

Unique Protocol Identification Number
NCT05827042
Brief Title
Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion
Official Title
Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Endovascular Thrombectomy on Acute Basilar Artery Occlusion - a Multicenter, Randomized Controlled, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of University of Science and Technology of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basilar Artery Occlusion, Acute Cerebrovascular Accident, Stroke Due to Basilar Artery Occlusion
Keywords
Thrombectomy, thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular thrombectomy alone
Arm Type
Experimental
Arm Description
Patients will receive endovascular thrombectomy without intravenous thrombolysis.
Arm Title
Intravenous thrombolysis plus endovascular thrombectomy
Arm Type
Active Comparator
Arm Description
Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
Intervention Type
Drug
Intervention Name(s)
Intravenous thrombolysis
Other Intervention Name(s)
Alteplase or Tenecteplase
Intervention Description
Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.
Intervention Type
Procedure
Intervention Name(s)
Endovascular thrombectomy
Intervention Description
Endovascular thrombectomy
Primary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)
Description
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
Secondary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days)
Description
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
Title
Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days)
Description
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
Title
Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 days)
Description
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
Title
Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days)
Description
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
Title
Score on the National Institute of Health Stroke Scale (NIHSS) at 24 hours
Description
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
24 hours after procedure
Title
Score on the NIHSS at 5-7 days or discharge
Description
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
Title
Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days)
Description
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
Title
level of activities of daily living (Barthel index, BI) at 90 days (±14 days)
Description
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
90 (± 14 days) after procedure
Title
Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy
Description
Evaluate effect of intravenous thrombolysis on reperfusion
Time Frame
within 5 minutes at angiography
Title
Successful reperfusion on final angiography of thrombectomy
Description
Evaluate effect of thrombectomy on reperfusion
Time Frame
Within 5 minutes at final angiography of thrombectomy
Title
Successful recanalization on CT or MR angiography within 72 hours
Description
Evaluate vascular patency after treatment
Time Frame
Within 72 hours after procedure
Title
Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours
Description
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
Other Pre-specified Outcome Measures:
Title
Symptomatic intracerebral hemorrhage (sICH) within 72 hours
Description
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
Title
Any intracerebral hemorrhage within 72 hours
Description
Evaluate intracerebral hemorrhage
Time Frame
Within 72 hours after procedure
Title
Overall mortality at 7 (± 2 days) and 90 (± 14 days)
Description
Evaluate death rate
Time Frame
7 (± 2 days) and 90 (± 14 days) after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery; Time from stroke onset to randomization within 4.5 hours of estimated time of basilar artery occlusion; Patient's age ≥ 18 years; Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery; Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria; Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10; The patient or patient's legal representative signs the informed consent form. Exclusion Criteria: CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds is allowed); Pre-stroke modified Rankin scale (mRS) score ≥ 2; Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) <5; Pregnant or lactating women; Allergy to contrast agent or nitinol alloy; Life expectancy<1 year; CTA/MRA/DSA show vascular tortuosity, anatomical variation or artery dissection, which would make it difficult to perform endovascular treatment; Participating in other clinical trials; Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, which can not be controlled by antihypertensive drugs; Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; oral anticoagulant with international normalized ratio (INR) > 1.7; or novel oral anticoagulant within prior 48 hours; Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L), platelet< 100*109/L; Renal insufficiency defined as serum creatinine >2.0 mg/dl (or 176.8 μ mol/l), glomerular filtration rate <30 mL/min, need for hemodialysis or peritoneal dialysis; Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc); The patient has acute ischemic cerebral infarction within 3 months from randomization; The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis; The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition; CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle; Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination; CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion; Patients with intracranial tumors (except small meningiomas); Patients who received intravenous thrombolytics treatment before the randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Hu, MD
Phone
+8615155510611
Email
andinghu@ustc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Hu, MD
Organizational Affiliation
The First Affiliated Hospital of University of Science and Technology of China
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of University of Science and Technology of China
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Hu, MD
Phone
+8615155510611
Email
andinghu@ustc.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

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