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

July 28, 2018 updated by: Xinfeng Liu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • Xinqiao Hospital, The Third Military Medical University
    • Anhui
      • Bengbu, Anhui, China, 233010
        • 123rd Hospital of The People's Liberation Army
      • Hefei, Anhui, China, 230001
        • Anhui Provincial Hospital
      • Hefei, Anhui, China
        • The First Affiliated Hospital of An'hui Medical University
      • Huainan, Anhui, China
        • the First People's Hospital of Huainan
      • Lu'an, Anhui, China, 237005
        • Lu'an Affiliated Hospital of Anhui Medical University
      • Wuhu, Anhui, China, 241001
        • Yijishan Hospital of Wannan Medical College
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital, Third Military Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Fuzhou General Hospital of Nanjing Military Region
      • Xiamen, Fujian, China, 361004
        • Zhongshan Hospital Xiamen University
      • Xiamen, Fujian, China
        • 175th hospital of PLA, the Affiliated Southeast Hospital of Xiamen University
      • Xiamen, Fujian, China
        • Affiliated Zhongshan Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong No.2 Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510507
        • The Chinese Armed Police Force Guangdong Armed Police Corps hospital
      • Maoming, Guangdong, China
        • Maoming People's Hospital
      • Shenzhen, Guangdong, China
        • Shenzhen Nanshan Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450003
        • Henan Provincial People's Hospital,Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China
        • Wuhan No.1 hospital
      • Wuhan, Hubei, China
        • Hubei Zhongshan Hospital
    • Hunan
      • Changsha, Hunan, China
        • Changsha Central Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Jinling Hospital, Medical School of Nanjing University
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital, Nanjing Medical University
      • Nantong, Jiangsu, China, 226001
        • Affiliated Hospital Of Nantong University
      • Wuxi, Jiangsu, China
        • 101st hospital of PLA
      • Xuzhou, Jiangsu, China
        • Xuzhou Central Hospital
      • Xuzhou, Jiangsu, China
        • The Second Affiliated Hospital of Xuzhou Medical University
      • Yancheng, Jiangsu, China
        • the Third People's Hospital of Yancheng
      • Yangzhou, Jiangsu, China
        • Northern Jiangsu People's Hospital
      • Yangzhou, Jiangsu, China, 225012
        • Yangzhou No.1 People's Hospital
      • Yangzhou, Jiangsu, China
        • the First People's Hospital of Yangzhou， Yangzhou University
      • Yangzhou, Jiangsu, China
        • Yangzhou Hongquan Hospital
    • Shandong
      • Linyi, Shandong, China, 276002
        • Linyi People's Hospital
      • Qingdao, Shandong, China
        • Qingdao Municipal Hospital
      • Qingdao, Shandong, China, 266005
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, China, 271099
        • Taian City Central Hospital
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Military General Hospital
      • Chengdu, Sichuan, China
        • Sichuan People's Hospital
      • Mianyang, Sichuan, China
        • Mianyang Central Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China
        • the First People's Hospital of Hangzhou,Nanjing Medical University
      • Lishui, Zhejiang, China
        • Lishui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard medical therapy
Patients receive standard medical therapy alone.
Other: standard medical therapy
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.
Experimental: endovascular + standard medical therapy
Patients receive endovascular treatment plus standard medical therapy.
Other: standard medical therapy
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.
Device: endovascular treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS)
Time Frame: at 90 days from randomization
A score of 0-3 will be considered as the favorable outcome.
at 90 days from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score 0-2
Time Frame: at 90 days from randomization
at 90 days from randomization
Change of mRS score(shift analysis)
Time Frame: at 90 days from randomization
at 90 days from randomization
Vessel recanalization rate evaluated by CT angiography or MRA
Time Frame: at 24 hours from randomization
at 24 hours from randomization
PC-ASPECT score on CT/MRI
Time Frame: at 24 hours from randomization
at 24 hours from randomization
GCS score
Time Frame: at 24 hours from randomization
at 24 hours from randomization
NIHSS score
Time Frame: at 24 hours from randomization
at 24 hours from randomization
GCS score
Time Frame: at 5-7 days from randomization
at 5-7 days from randomization
NIHSS score
Time Frame: at 5-7 days from randomization
at 5-7 days from randomization
EuroQol 5D (EQ-5D)
Time Frame: at 90 days from randomization
at 90 days from randomization
mortality
Time Frame: at 3 months from randomization
at 3 months from randomization
symptomatic intracerebral hemorrhage (ICH)
Time Frame: within 24 hours from randomization
within 24 hours from randomization
incidence of non-intracerebral hemorrhage complications
Time Frame: at 90 days from randomization
at 90 days from randomization
severity of non-intracerebral hemorrhage complications
Time Frame: within 90 days from randomization
within 90 days from randomization
incidence of nonbleeding severe adverse events (SAEs)
Time Frame: within 90 days from randomization
within 90 days from randomization
severity of nonbleeding severe adverse events (SAEs)
Time Frame: within 90 days from randomization
within 90 days from randomization
incidence of procedure and device related complications
Time Frame: within 90 days from randomization
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
within 90 days from randomization
severity of procedure and device related complications
Time Frame: within 90 days from randomization
i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
within 90 days from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinfeng Liu

Investigators

  • Study Chair: Xinfeng Liu, Doctor, Departmnet of Neurology, Jinling Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 27, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLH-NEURO-2015-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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