Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

Acute Ischemic Stroke Clinical Trial

— BEST-BAO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631847
• Other study ID #: GFQ18981838913
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: February 2024
• Source: Sichuan Academy of Medical Sciences
• Contact: Fu-Qiang Guo, M.D.
• Phone: +8618981838913
• Email: guofuqiang2005[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: May 31, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Alteplase
• Arterial Occlusive Diseases
• Basilar Artery Occlusion
• Endovascular Treatment
• Ischemia
• Ischemic Stroke
• Stroke
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
China	Bazhong Central Hospital	Bazhong	Sichuan
China	Chengdu Third People's Hospital	Chengde	Sichuan
China	Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	Chengdu First People's Hospital	Chengdu	Sichuan
China	Chengdu Second People's Hospital	Chengdu	Sichuan
China	Chongzhou People's Hospital	Chengdu	Sichuan
China	Dayi County People's Hospital	Chengdu	Sichuan
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Western Theater General Hospital	Chengdu	Sichuan
China	Banan Hospital Affiliated to Chongqing Medical University	Chongqing	Chongqing
China	Chongqing Sanbo Chang'an Hospital	Chongqing	Chongqing
China	Hechuan District People's Hospital	Chongqing	Chongqing
China	Liangping District People's Hospital	Chongqing	Chongqing
China	The First People's Hospital of Liangjiang New Area	Chongqing	Chongqing
China	Yubei District People's Hospital	Chongqing	Chongqing
China	Deyang People's Hospital	Deyang	Sichuan
China	Guang'an Central Hospital	Guang'an	Sichuan
China	Guangyuan Central Hospital	Guangyuan	Sichuan
China	Guangyuan First People's Hospital	Guangyuan	Sichuan
China	The Fifth People's Hospital Affiliated to Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui
China	Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital	Kaili	Guizhou
China	Kashgar First People's Hospital	Kashgar	Xinjiang
China	Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Mianyang 404 Hospital	Mianyang	Sichuan
China	Mianyang Central Hospital	Mianyang	Sichuan
China	Mianyang Third People's Hospital	Mianyang	Sichuan
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	Langzhong People's Hospital	Nanchong	Sichuan
China	Nanchong Central Hospital	Nanchong	Sichuan
China	Yilong County People's Hospital	Nanchong	Sichuan
China	Nanyang Central Hospital	Nanyang	Henan
China	Neijiang Second People's Hospital	Neijiang	Sichuan
China	Panzhihua Central Hospital	Panzhihua	Sichuan
China	Suining Central Hospital	Suining	Sichuan
China	Suining First People's Hospital	Suining	Sichuan
China	Tongren People's Hospital	Tongren	Guizhou
China	Qianxinan Buyei and Miao Autonomous Prefecture People's Hospital	Xingyi	Guizhou
China	Ya'an People's Hospital	Ya'an	Sichuan
China	Yibin First People's Hospital	Yibin	Sichuan
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Zhuzhou Central Hospital	Zhuzhou	Hunan
China	Zigong First People's Hospital	Zigong	Sichuan
China	Zigong Third People's Hospital	Zigong	Sichuan
China	Ziyang First People's Hospital	Ziyang	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Academy of Medical Sciences	Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRS (the modified Rankin Scale) score	The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.	At 90 day after procedure
Secondary	NIHSS (the National Institutes of Health Stroke Scale) score	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.	At 24 hours and 5-7 days after procedure
Secondary	Recanalization rate	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).	At 24-48 hours after endovascular treatment
Secondary	Final infarct volume	The final infarct volume will be assessed with the use of an automated, validated algorithm based on magnetic resource imaging test.	At 5-7 days after procedure
Secondary	All-cause mortality	The proportion of total deaths caused by various reasons in both arms	At 90 days after procedure
Secondary	eTICI (Extended Treatment In Cerebral Ischemia) score	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.	Immediately after endovascular treatment
Secondary	sICH (symptomatic intracranial hemorrhage) rate	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.	At 7 days after endovascular treatment
Secondary	Comparison of mRS 0-1 and mRS 2-6	The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.	At 90 days after procedure
Secondary	Comparison of mRS 0-2 and mRS 3-6	The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.	At 90 days after procedure
Secondary	Comparison of mRS 0-3 and mRS 4-6	The mRS score is an ordinal hierarchical scale ranging from 0 to 5, with higher scores suggesting more severe disability.	At 90 days after procedure
Secondary	EQ-5D-5L (the European Quality of Life 5-Dimension 5-Level) score	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.	At 90 days after procedure
Secondary	Barthel Index	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.	At 90 days after procedure
Secondary	Proportion of new cerebral infarction	The proportion of the new cerebral infarction compared with the onset of symptoms evaluated with magnetic resource imaging test	At 5-7 days after procedure
Secondary	Incidence of pseudoaneurysm at puncture site	The pseudoaneurysm at puncture site caused by various reasons is one of the important indicators reflecting puncture complications.	At 5-7 days after procedure
Secondary	Incidence of hematoma at puncture site	The hematoma at puncture site caused by various reasons is one of the important indicators reflecting puncture complications.	At 5-7 days after procedure