- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04743076
A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion (BASILAR-2)
Standard Medical Treatment Plus Endovascular Treatment Versus Standard Medical Treatment Alone for Stroke Patient With Large Vessel Occlusion In The Posterior Circulation: A Multicenter, Randomized, Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.
The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Anhui
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Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
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Wuhu, Anhui, China, 241000
- Yijishan Hospital of Wannan Medical College
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Chongqing
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Banan, Chongqing, China, 400040
- Banan District People's Hospital
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Chongqing, Chongqing, China, 400037
- Xinqiao Hospital of Army Medical University
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Guangdong
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Jiangmen, Guangdong, China, 529000
- Wuyi Traditional Chinese Medicine Hospital
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Jiangmen, Guangdong, China, 529030
- Jiangmen Central Hospital
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Maoming, Guangdong, China, 525000
- Maoming Traditional Chinese Medicine Hospital
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Zhongshan, Guangdong, China, 528400
- Chinese Medical Hospital of Zhongshan
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Guangxi
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Guilin, Guangxi, China, 541000
- The 924th Hospital of CPLA
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Guizhou
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Danzhai, Guizhou, China, 557500
- Danzhai People's Hospital
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Henan
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Nanyang, Henan, China, 473000
- Nanyang Central Hospital
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Hubei
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Wuhan, Hubei, China, 430000
- Wuhan No. 1 Hospital
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Jiangsu
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Wuxi, Jiangsu, China, 214000
- The 904th Hospital of CPLA
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Xuzhou, Jiangsu, China, 221000
- Xuzhou Central Hospital
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Jilin
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Changchun, Jilin, China, 130000
- The First Affiliated Hospital of Jilin University
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Sichuan
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Luzhou, Sichuan, China, 646000
- The Affiliated Hospital of Southwest Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: i. 18 ~ 80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
- NIHSS score ≥ 10 before randomization;
- VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
- Time from stroke onset to randomization within 23.5 hours;
- Written informed consent is obtained from patients and/or their legal representatives.
Exclusion Criteria:
- CT or MR evidence of intracranial hemorrhage;
- Pre-morbidity with a modified Rankin scale score ≥ 3;
- The patient is in deep coma;
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
- Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
- Imaging manifestations of diffuse bilateral brainstem ischemia;
- Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
- Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
- Participating in other clinical trials;
- Any terminal illness with life expectancy less than 6 months;
- Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Past neurological or psychiatric diseases that hinder the assessment of neurological function;
- Unlikely to be available for 90-day follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Standard medical treatment plus endovascular treatment
|
Endovascular treatment
Standard medical treatment
|
Active Comparator: Control group
Standard medical treatment alone
|
Standard medical treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin scale score
Time Frame: 90 days
|
disability level
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of a score of 0~2 on modified Rankin scale
Time Frame: 90 days
|
Functional independence
|
90 days
|
Improvement in NIHSS between baseline and 24 hours
Time Frame: at 24 hours from randomization
|
neurological changes
|
at 24 hours from randomization
|
Improvement in NIHSS between baseline and 5~7d
Time Frame: at 5~7 days from randomization
|
neurological changes
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at 5~7 days from randomization
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Improvement in GCS between baseline and 24 hours
Time Frame: at 24 hours from randomization
|
neurological changes
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at 24 hours from randomization
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Improvement in GCS between baseline and 24 hours
Time Frame: at 5~7 days from randomization
|
neurological changes
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at 5~7 days from randomization
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Asymptomatic intracranial hemorrhage within 48 hours
Time Frame: within 48 hours after endovascular treatment
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evaluate intracranial hemorrhage
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within 48 hours after endovascular treatment
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Procedural-related complications and severe adverse events
Time Frame: within 90 days
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evaluate complications and any adverse events
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within 90 days
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Serious non-hemorrhagic adverse events
Time Frame: within 90 days
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evaluate complications and any adverse events
|
within 90 days
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Score of 90-day EQ-5D scale
Time Frame: 90 days
|
Functional independence
|
90 days
|
Mortality within 90 days
Time Frame: 90 days
|
evaluate death rate of the two treatment groups
|
90 days
|
Symptomatic intracranial hemorrhage within 48 hours
Time Frame: within 48 hours after endovascular treatment
|
evaluate intracranial hemorrhage
|
within 48 hours after endovascular treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Qingwu Yang, MD, Neurology, Xinqiao Hospital of the Army Medical University
- Principal Investigator: Wenjie Zi, MD, Neurology, Xinqiao Hospital of the Army Medical University
- Principal Investigator: Raul G Nogueira, MD, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
- Principal Investigator: Jeffrey L Saver, MD, Neurology, University of California, Los Angeles, USA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASILAR-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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