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A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion (BASILAR-2)

Primary Purpose

Vertebrobasilar Stroke

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endovascular treatment
Standard medical treatment
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebrobasilar Stroke focused on measuring endovascular treatment, thrombolysis

Eligibility Criteria

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

Inclusion Criteria:

  1. Age: i. 18 ~ 80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
  2. NIHSS score ≥ 10 before randomization;
  3. VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
  4. Time from stroke onset to randomization within 23.5 hours;
  5. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

  1. CT or MR evidence of intracranial hemorrhage;
  2. Pre-morbidity with a modified Rankin scale score ≥ 3;
  3. The patient is in deep coma;
  4. Currently in pregnant or lactating or serum beta HCG test is positive on admission;
  5. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
  6. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
  7. Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
  8. Imaging manifestations of diffuse bilateral brainstem ischemia;
  9. Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
  10. Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
  11. Participating in other clinical trials;
  12. Any terminal illness with life expectancy less than 6 months;
  13. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
  14. Past neurological or psychiatric diseases that hinder the assessment of neurological function;
  15. Unlikely to be available for 90-day follow-up.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Yijishan Hospital of Wannan Medical College
  • Banan District People's Hospital
  • Xinqiao Hospital of Army Medical University
  • Wuyi Traditional Chinese Medicine Hospital
  • Jiangmen Central Hospital
  • Maoming Traditional Chinese Medicine Hospital
  • Chinese Medical Hospital of Zhongshan
  • The 924th Hospital of CPLA
  • Danzhai People's Hospital
  • Nanyang Central Hospital
  • Wuhan No. 1 Hospital
  • The 904th Hospital of CPLA
  • Xuzhou Central Hospital
  • The First Affiliated Hospital of Jilin University
  • The Affiliated Hospital of Southwest Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Standard medical treatment plus endovascular treatment

Standard medical treatment alone

Outcomes

Primary Outcome Measures

Modified Rankin scale score
disability level

Secondary Outcome Measures

Rate of a score of 0~2 on modified Rankin scale
Functional independence
Improvement in NIHSS between baseline and 24 hours
neurological changes
Improvement in NIHSS between baseline and 5~7d
neurological changes
Improvement in GCS between baseline and 24 hours
neurological changes
Improvement in GCS between baseline and 24 hours
neurological changes
Asymptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage
Procedural-related complications and severe adverse events
evaluate complications and any adverse events
Serious non-hemorrhagic adverse events
evaluate complications and any adverse events
Score of 90-day EQ-5D scale
Functional independence
Mortality within 90 days
evaluate death rate of the two treatment groups
Symptomatic intracranial hemorrhage within 48 hours
evaluate intracranial hemorrhage

Full Information

First Posted
February 2, 2021
Last Updated
September 7, 2021
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT04743076
Brief Title
A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion
Acronym
BASILAR-2
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Suspended
Why Stopped
Withdrawal of funding
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
May 16, 2024 (Anticipated)
Study Completion Date
May 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

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
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebrobasilar Stroke
Keywords
endovascular treatment, thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Standard medical treatment plus endovascular treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard medical treatment alone
Intervention Type
Procedure
Intervention Name(s)
Endovascular treatment
Intervention Description
Endovascular treatment
Intervention Type
Other
Intervention Name(s)
Standard medical treatment
Intervention Description
Standard medical treatment
Primary Outcome Measure Information:
Title
Modified Rankin scale score
Description
disability level
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Rate of a score of 0~2 on modified Rankin scale
Description
Functional independence
Time Frame
90 days
Title
Improvement in NIHSS between baseline and 24 hours
Description
neurological changes
Time Frame
at 24 hours from randomization
Title
Improvement in NIHSS between baseline and 5~7d
Description
neurological changes
Time Frame
at 5~7 days from randomization
Title
Improvement in GCS between baseline and 24 hours
Description
neurological changes
Time Frame
at 24 hours from randomization
Title
Improvement in GCS between baseline and 24 hours
Description
neurological changes
Time Frame
at 5~7 days from randomization
Title
Asymptomatic intracranial hemorrhage within 48 hours
Description
evaluate intracranial hemorrhage
Time Frame
within 48 hours after endovascular treatment
Title
Procedural-related complications and severe adverse events
Description
evaluate complications and any adverse events
Time Frame
within 90 days
Title
Serious non-hemorrhagic adverse events
Description
evaluate complications and any adverse events
Time Frame
within 90 days
Title
Score of 90-day EQ-5D scale
Description
Functional independence
Time Frame
90 days
Title
Mortality within 90 days
Description
evaluate death rate of the two treatment groups
Time Frame
90 days
Title
Symptomatic intracranial hemorrhage within 48 hours
Description
evaluate intracranial hemorrhage
Time Frame
within 48 hours after endovascular treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingwu Yang, MD
Organizational Affiliation
Neurology, Xinqiao Hospital of the Army Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenjie Zi, MD
Organizational Affiliation
Neurology, Xinqiao Hospital of the Army Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul G Nogueira, MD
Organizational Affiliation
Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey L Saver, MD
Organizational Affiliation
Neurology, University of California, Los Angeles, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Yijishan Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241000
Country
China
Facility Name
Banan District People's Hospital
City
Banan
State/Province
Chongqing
ZIP/Postal Code
400040
Country
China
Facility Name
Xinqiao Hospital of Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Wuyi Traditional Chinese Medicine Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529000
Country
China
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Facility Name
Maoming Traditional Chinese Medicine Hospital
City
Maoming
State/Province
Guangdong
ZIP/Postal Code
525000
Country
China
Facility Name
Chinese Medical Hospital of Zhongshan
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528400
Country
China
Facility Name
The 924th Hospital of CPLA
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541000
Country
China
Facility Name
Danzhai People's Hospital
City
Danzhai
State/Province
Guizhou
ZIP/Postal Code
557500
Country
China
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
Wuhan No. 1 Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The 904th Hospital of CPLA
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study data without patient information
IPD Sharing Time Frame
Related papers published 3 months later, the IPD will be shared
IPD Sharing Access Criteria
yangqwmlys@163.com ziwenjie1981@163.com
Citations:
PubMed Identifier
32080711
Citation
Writing Group for the BASILAR Group; Zi W, Qiu Z, Wu D, Li F, Liu H, Liu W, Huang W, Shi Z, Bai Y, Liu Z, Wang L, Yang S, Pu J, Wen C, Wang S, Zhu Q, Chen W, Yin C, Lin M, Qi L, Zhong Y, Wang Z, Wu W, Chen H, Yao X, Xiong F, Zeng G, Zhou Z, Wu Z, Wan Y, Peng H, Li B, Hu X, Wen H, Zhong W, Wang L, Jin P, Guo F, Han J, Fu X, Ai Z, Tian X, Feng X, Sun B, Huang Z, Li W, Zhou P, Tu M, Sun X, Li H, He W, Qiu T, Yuan Z, Yue C, Yang J, Luo W, Gong Z, Shuai J, Nogueira RG, Yang Q. Assessment of Endovascular Treatment for Acute Basilar Artery Occlusion via a Nationwide Prospective Registry. JAMA Neurol. 2020 May 1;77(5):561-573. doi: 10.1001/jamaneurol.2020.0156.
Results Reference
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A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion

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