BEST-BAO: Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

Sponsor

Sichuan Academy of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05631847

Collaborator

Sichuan Provincial People's Hospital (Other)

336

Enrollment

Locations

Arms

52.5

Anticipated Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Two recent randomized controlled trials (BAOCHE and ATTENTION) have confirmed the efficacy and safety of endovascular therapy in patient with acute ischemic stroke (AIS) due to basilar artery occlusion (BAO). However, it is still inconclusive whether there is any differences between endovascular therapy with or without bridging intravenous thrombolysis in acute BAO. So far, no randomized controlled trial has been conducted specifically for endovascular therapy with or without intravenous thrombolysis for ischemic stroke due to BAO. Therefore, this study plans to conduct a prospective, multicenter, randomized controlled trial to compare the functional outcomes between endovascular therapy with and without intravenous thrombolysis in patient with AIS due to BAO.

This study is a multicenter, parallel, open label, randomized controlled trial comparing direct endovascular therapy versus endovascular therapy bridging intravenous thrombolysis (IVT). This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6.

The main outcome is the 3-month mRS scale score. Secondary outcomes included NIHSS at 24 hours and 7 days after surgery, CTA vascular recanalization at 24-72 hours, mRS at 5-7 days, and infarct volume. The safety outcomes included 90-day mortality and the incidence of sICH.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Basilar Artery Occlusion Thrombosis Alteplase Endovascular Treatment	Procedure: Endovascular treatment Drug: Intravenous thrombolysis (Alteplase)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Endovascular Treatment With Or Without Intravenous Alteplase In Acute Ischemic Stroke Of Basilar Artery Occlusion: A Multicenter, Prospective, Randomized Controlled Trial (BEST-BAO)

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Jan 15, 2027

Anticipated Study Completion Date :

May 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Direct endovascular treatment group Direct endovascular treatment (EVT) without intravenous thrombolysis (IVT)	Procedure: Endovascular treatment It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team.
Active Comparator: Bridging treatment group Intravenous thrombolysis (IVT) followed by endovascular treatment (EVT)	Procedure: Endovascular treatment It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team. Drug: Intravenous thrombolysis (Alteplase) Alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.

Arm

Intervention/Treatment

Sham Comparator: Direct endovascular treatment group

Direct endovascular treatment (EVT) without intravenous thrombolysis (IVT)

Procedure: Endovascular treatment

It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team.

Active Comparator: Bridging treatment group

Intravenous thrombolysis (IVT) followed by endovascular treatment (EVT)

Procedure: Endovascular treatment

Drug: Intravenous thrombolysis (Alteplase)

Alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.

Outcome Measures

Primary Outcome Measures

mRS (the modified Rankin Scale) score [At 90 day after procedure]
The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.

Secondary Outcome Measures

NIHSS (the National Institutes of Health Stroke Scale) score [At 24 hours and 5-7 days after procedure]
The NIHSS score is an ordinal hierarchical scale to evaluate the symptomatic severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores suggesting a more severe deficit.
Recanalization rate [At 24-48 hours after endovascular treatment]
The recanalization rate at 24-72 hours after endovascular treatment, assessed by computerized tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
Final infarct volume [At 5-7 days after procedure]
The final infarct volume will be assessed with the use of an automated, validated algorithm based on magnetic resource imaging test.
All-cause mortality [At 90 days after procedure]
The proportion of total deaths caused by various reasons in both arms
eTICI (Extended Treatment In Cerebral Ischemia) score [Immediately after endovascular treatment]
The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores suggesting better antegrade reperfusion of the previously occluded target artery ischemic territory.
sICH (symptomatic intracranial hemorrhage) rate [At 7 days after endovascular treatment]
The sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 7 days or any hemorrhage leading to death.
Comparison of mRS 0-1 and mRS 2-6 [At 90 days after procedure]
The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.
Comparison of mRS 0-2 and mRS 3-6 [At 90 days after procedure]
The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.
Comparison of mRS 0-3 and mRS 4-6 [At 90 days after procedure]
The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.
EQ-5D-5L (the European Quality of Life 5-Dimension 5-Level) score [At 90 days after procedure]
The EQ-5D-5L score is an ordinal hierarchical scale to evaluate the quality of life. Scores range from -0.39 to 1, with higher scores indicating a better quality of life.
Barthel Index [At 90 days after procedure]
dichotomized as 0 to 94 The Barthel Index is an ordinal hierarchical scale to evaluate the daily activities. Scores range from 0 to 100. The Barthel Index will be dichotomized as 0 to 94 vs. 95 to 100, with a score of 95 to 100 indicating no interference with daily activities.
Proportion of new cerebral infarction [At 5-7 days after procedure]
The proportion of the new cerebral infarction compared with the onset of symptoms evaluated with magnetic resource imaging test
Incidence of pseudoaneurysm at puncture site [At 5-7 days after procedure]
The pseudoaneurysm at puncture site caused by various reasons is one of the important indicators reflecting puncture complications.
Incidence of hematoma at puncture site [At 5-7 days after procedure]
The hematoma at puncture site caused by various reasons is one of the important indicators reflecting puncture complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A clinical diagnosis of acute ischemic stroke (AIS);
Caused by basilar artery occlusion (BAO) confirmed by CTA, MRA, or DSA;
CT or MRI ruling out intracranial hemorrhage;
Eligible for intravenous thrombolysis (IVT) and endovascular treatment (EVT) (within 4.5 hours after symptom onset);
A score of at least 6 on the NIHSS score;
Age of 18 years or older;
Written informed consent.

Exclusion Criteria:

Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
Any contra-indication for intravenous thrombolysis (IVT), according to guidelines of the American Heart Association, i.e.:
Arterial blood pressure exceeding 185/110 mmHg
Blood glucose less than 2.7 or over 22.2 mmol/L
Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
Serious head trauma in the previous 3 months
Major surgery or serious trauma in the previous 2 weeks
Gastrointestinal or urinary tract hemorrhage in the previous 3 weeks
Previous intracerebral hemorrhage
Use of anticoagulant with INR exceeding 1.7
Known thrombocyte count less than 100 x 10^9/L
Treatment with direct thrombin or factor X inhibitors
Treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.

Contacts and Locations

Locations

	Site	City	State	Country
1	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui	China
2	Banan Hospital Affiliated to Chongqing Medical University	Chongqing	Chongqing	China
3	Chongqing Sanbo Chang'an Hospital	Chongqing	Chongqing	China
4	Hechuan District People's Hospital	Chongqing	Chongqing	China
5	Liangping District People's Hospital	Chongqing	Chongqing	China
6	The First People's Hospital of Liangjiang New Area	Chongqing	Chongqing	China
7	Yubei District People's Hospital	Chongqing	Chongqing	China
8	The Fifth People's Hospital Affiliated to Southern Medical University	Guangzhou	Guangdong	China
9	Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital	Kaili	Guizhou	China
10	Tongren People's Hospital	Tongren	Guizhou	China
11	Qianxinan Buyei and Miao Autonomous Prefecture People's Hospital	Xingyi	Guizhou	China
12	Nanyang Central Hospital	Nanyang	Henan	China
13	Zhuzhou Central Hospital	Zhuzhou	Hunan	China
14	Bazhong Central Hospital	Bazhong	Sichuan	China
15	Chengdu Third People's Hospital	Chengde	Sichuan	China
16	Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan	China
17	Chengdu Fifth People's Hospital	Chengdu	Sichuan	China
18	Chengdu First People's Hospital	Chengdu	Sichuan	China
19	Chengdu Second People's Hospital	Chengdu	Sichuan	China
20	Chongzhou People's Hospital	Chengdu	Sichuan	China
21	Dayi County People's Hospital	Chengdu	Sichuan	China
22	Western Theater General Hospital	Chengdu	Sichuan	China
23	Deyang People's Hospital	Deyang	Sichuan	China
24	Guang'an Central Hospital	Guang'an	Sichuan	China
25	Guangyuan Central Hospital	Guangyuan	Sichuan	China
26	Guangyuan First People's Hospital	Guangyuan	Sichuan	China
27	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China
28	Mianyang 404 Hospital	Mianyang	Sichuan	China
29	Mianyang Central Hospital	Mianyang	Sichuan	China
30	Mianyang Third People's Hospital	Mianyang	Sichuan	China
31	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan	China
32	Langzhong People's Hospital	Nanchong	Sichuan	China
33	Nanchong Central Hospital	Nanchong	Sichuan	China
34	Yilong County People's Hospital	Nanchong	Sichuan	China
35	Neijiang Second People's Hospital	Neijiang	Sichuan	China
36	Panzhihua Central Hospital	Panzhihua	Sichuan	China
37	Suining Central Hospital	Suining	Sichuan	China
38	Suining First People's Hospital	Suining	Sichuan	China
39	Ya'an People's Hospital	Ya'an	Sichuan	China
40	Yibin First People's Hospital	Yibin	Sichuan	China
41	Yibin Second People's Hospital	Yibin	Sichuan	China
42	Zigong First People's Hospital	Zigong	Sichuan	China
43	Zigong Third People's Hospital	Zigong	Sichuan	China
44	Ziyang First People's Hospital	Ziyang	Sichuan	China
45	Kashgar First People's Hospital	Kashgar	Xinjiang	China