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Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment (BEST)

Primary Purpose

Stroke Due to Basilar Artery Occlusion, Acute Cerebrovascular Accidents

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endovascular treatment
standard medical therapy
Sponsored by
Xinfeng Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Due to Basilar Artery Occlusion focused on measuring thrombectomy, rt-PA, stroke, endovascular treatment, randomized

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥18 years;
  2. Acute ischemic stroke consistent with infarction in the basilar artery territory;
  3. Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time;
  4. Written informed consent from patient or surrogate, if unable to provide consent.

Exclusion Criteria:

  1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation;
  2. Premorbid mRS ≥ 3 points;
  3. Currently in pregnant or lactating;
  4. Known serious sensitivity to radiographic contrast agents and nitinol metal;
  5. Current participation in another investigation drug or device study;
  6. Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication;
  7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time;
  8. Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%;
  9. Arterial tortuosity that would prevent the device from reaching the target vessel;
  10. Life expectancy less than 1 year;
  11. History of major hemorrhage in the past 6 months;
  12. Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus.
  13. Angiographic evidence of bilateral extended brainstem ischemia.

Sites / Locations

  • 123rd Hospital of The People's Liberation Army
  • Anhui Provincial Hospital
  • the First Affiliated Hospital of An'hui Medical University
  • the First People's Hospital of Huainan
  • Lu'an Affiliated Hospital of Anhui Medical University
  • Yijishan Hospital of Wannan Medical College
  • Daping Hospital, Third Military Medical University
  • Fuzhou General Hospital of Nanjing Military Region
  • Zhongshan Hospital Xiamen University
  • 175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
  • Affiliated Zhongshan Hospital of Xiamen University
  • Guangdong No.2 Provincial People's Hospital
  • The Chinese Armed Police Force Guangdong Armed Police Corps hospital
  • Maoming People's Hospital
  • Shenzhen Nanshan Hospital
  • Henan Provincial People's Hospital,Zhengzhou University
  • The First Affiliated Hospital of Zhengzhou University
  • Zhongnan Hospital of Wuhan University
  • Hubei Zhongshan Hospital
  • Wuhan No.1 Hospital
  • Changsha Central Hospital
  • Jinling Hospital, Medical School of Nanjing University
  • Nanjing First Hospital, Nanjing Medical University
  • Affiliated Hospital of Nantong University
  • 101st hospital of PLA
  • the Second Affiliated Hospital of Xuzhou Medical University
  • Xuzhou Central Hospital
  • the Third People's Hospital of Yancheng
  • Yangzhou No.1 People's Hospital
  • Northern Jiangsu People's Hospital
  • the First People's Hospital of Yangzhou， Yangzhou University
  • Yangzhou Hongquan Hospital
  • Linyi People's Hospital
  • The Affiliated Hospital of Qingdao University
  • Qingdao Municipal Hospital
  • Taian City Central Hospital
  • Yantai Yuhuangding Hospital
  • Chengdu Military General Hospital
  • Sichuan People's Hospital
  • Mianyang Central Hospital
  • the First People's Hospital of Hangzhou,Nanjing Medical University
  • Zhejiang Provincial People's Hospital
  • Lishui Central Hospital
  • Xinqiao Hospital, the Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard medical therapy

endovascular + standard medical therapy

Arm Description

Patients receive standard medical therapy alone.

Patients receive endovascular treatment plus standard medical therapy.

Outcomes

Primary Outcome Measures

modified Rankin Scale (mRS)
A score of 0-3 will be considered as the favorable outcome.

Secondary Outcome Measures

mRS score 0-2
Change of mRS score(shift analysis)
Vessel recanalization rate evaluated by CT angiography or MRA
PC-ASPECT score on CT/MRI
GCS score
NIHSS score
GCS score
NIHSS score
EuroQol 5D (EQ-5D)
mortality
symptomatic intracerebral hemorrhage (ICH)
incidence of non-intracerebral hemorrhage complications
severity of non-intracerebral hemorrhage complications
incidence of nonbleeding severe adverse events (SAEs)
severity of nonbleeding severe adverse events (SAEs)
incidence of procedure and device related complications
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
severity of procedure and device related complications
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.

Full Information

First Posted
April 16, 2015
Last Updated
July 28, 2018
Sponsor
Xinfeng Liu
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1. Study Identification

Unique Protocol Identification Number
NCT02441556
Brief Title
Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
Acronym
BEST
Official Title
Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xinfeng Liu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial will provide valuable insights into the safety and efficacy of endovascular treatment for acute ischemic stroke patients with basilar artery occlusion within 8 hours of estimated occlusion time.
Detailed Description
This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old. In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Due to Basilar Artery Occlusion, Acute Cerebrovascular Accidents
Keywords
thrombectomy, rt-PA, stroke, endovascular treatment, randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard medical therapy
Arm Type
Active Comparator
Arm Description
Patients receive standard medical therapy alone.
Arm Title
endovascular + standard medical therapy
Arm Type
Experimental
Arm Description
Patients receive endovascular treatment plus standard medical therapy.
Intervention Type
Device
Intervention Name(s)
endovascular treatment
Intervention Description
The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
Intervention Type
Other
Intervention Name(s)
standard medical therapy
Intervention Description
If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
Primary Outcome Measure Information:
Title
modified Rankin Scale (mRS)
Description
A score of 0-3 will be considered as the favorable outcome.
Time Frame
at 90 days from randomization
Secondary Outcome Measure Information:
Title
mRS score 0-2
Time Frame
at 90 days from randomization
Title
Change of mRS score(shift analysis)
Time Frame
at 90 days from randomization
Title
Vessel recanalization rate evaluated by CT angiography or MRA
Time Frame
at 24 hours from randomization
Title
PC-ASPECT score on CT/MRI
Time Frame
at 24 hours from randomization
Title
GCS score
Time Frame
at 24 hours from randomization
Title
NIHSS score
Time Frame
at 24 hours from randomization
Title
GCS score
Time Frame
at 5-7 days from randomization
Title
NIHSS score
Time Frame
at 5-7 days from randomization
Title
EuroQol 5D (EQ-5D)
Time Frame
at 90 days from randomization
Title
mortality
Time Frame
at 3 months from randomization
Title
symptomatic intracerebral hemorrhage (ICH)
Time Frame
within 24 hours from randomization
Title
incidence of non-intracerebral hemorrhage complications
Time Frame
at 90 days from randomization
Title
severity of non-intracerebral hemorrhage complications
Time Frame
within 90 days from randomization
Title
incidence of nonbleeding severe adverse events (SAEs)
Time Frame
within 90 days from randomization
Title
severity of nonbleeding severe adverse events (SAEs)
Time Frame
within 90 days from randomization
Title
incidence of procedure and device related complications
Description
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Time Frame
within 90 days from randomization
Title
severity of procedure and device related complications
Description
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
Time Frame
within 90 days from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Acute ischemic stroke consistent with infarction in the basilar artery territory; Basilar artery occlusion confirmed by CTA/MRA/DSA, within 8 hours of estimated occlusion time; Written informed consent from patient or surrogate, if unable to provide consent. Exclusion Criteria: Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of Cerebral hemorrhage on presentation; Premorbid mRS ≥ 3 points; Currently in pregnant or lactating; Known serious sensitivity to radiographic contrast agents and nitinol metal; Current participation in another investigation drug or device study; Uncontrolled hypertension defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg that cannot be controlled except with continuous parenteral antihypertensive medication; Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with INR >1.7 or institutionally equivalent prothrombin time; Baseline lab values: glucose < 50 mg/dl or > 400 mg/dl, platelets <100*109/L, or Hct<25%; Arterial tortuosity that would prevent the device from reaching the target vessel; Life expectancy less than 1 year; History of major hemorrhage in the past 6 months; Angiographic evidence of significant cerebellar mass effect or acute hydrocephalus. Angiographic evidence of bilateral extended brainstem ischemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu, Doctor
Organizational Affiliation
Departmnet of Neurology, Jinling Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
123rd Hospital of The People's Liberation Army
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233010
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
the First Affiliated Hospital of An'hui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
the First People's Hospital of Huainan
City
Huainan
State/Province
Anhui
Country
China
Facility Name
Lu'an Affiliated Hospital of Anhui Medical University
City
Lu'an
State/Province
Anhui
ZIP/Postal Code
237005
Country
China
Facility Name
Yijishan Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Region
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Affiliated Zhongshan Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Guangdong No.2 Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Chinese Armed Police Force Guangdong Armed Police Corps hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510507
Country
China
Facility Name
Maoming People's Hospital
City
Maoming
State/Province
Guangdong
Country
China
Facility Name
Shenzhen Nanshan Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Henan Provincial People's Hospital,Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Name
Hubei Zhongshan Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jinling Hospital, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
101st hospital of PLA
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
the Second Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
the Third People's Hospital of Yancheng
City
Yancheng
State/Province
Jiangsu
Country
China
Facility Name
Yangzhou No.1 People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225012
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
the First People's Hospital of Yangzhou， Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Yangzhou Hongquan Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276002
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266005
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Taian City Central Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271099
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264099
Country
China
Facility Name
Chengdu Military General Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sichuan People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
Country
China
Facility Name
the First People's Hospital of Hangzhou,Nanjing Medical University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Lishui Central Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Facility Name
Xinqiao Hospital, the Third Military Medical University
City
Chongqing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment

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