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

September 7, 2021 updated by: Zhongming Qiu, Xinqiao Hospital of Chongqing

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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

386

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

    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Wuhu, Anhui, China, 241000
        • Yijishan Hospital of Wannan Medical College
    • Chongqing
      • Banan, Chongqing, China, 400040
        • Banan District People's Hospital
      • Chongqing, Chongqing, China, 400037
        • Xinqiao Hospital of Army Medical University
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Wuyi Traditional Chinese Medicine Hospital
      • Jiangmen, Guangdong, China, 529030
        • Jiangmen Central Hospital
      • Maoming, Guangdong, China, 525000
        • Maoming Traditional Chinese Medicine Hospital
      • Zhongshan, Guangdong, China, 528400
        • Chinese Medical Hospital of Zhongshan
    • Guangxi
      • Guilin, Guangxi, China, 541000
        • The 924th Hospital of CPLA
    • Guizhou
      • Danzhai, Guizhou, China, 557500
        • Danzhai People's Hospital
    • Henan
      • Nanyang, Henan, China, 473000
        • Nanyang Central Hospital
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Wuhan No. 1 Hospital
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • The 904th Hospital of CPLA
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
    • Jilin
      • Changchun, Jilin, China, 130000
        • The First Affiliated Hospital of Jilin University
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Southwest Medical University

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: 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.

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: 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

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
at 5~7 days from randomization
Improvement in GCS between baseline and 24 hours
Time Frame: at 24 hours from randomization
neurological changes
at 24 hours from randomization
Improvement in GCS between baseline and 24 hours
Time Frame: at 5~7 days from randomization
neurological changes
at 5~7 days from randomization
Asymptomatic intracranial hemorrhage within 48 hours
Time Frame: within 48 hours after endovascular treatment
evaluate intracranial hemorrhage
within 48 hours after endovascular treatment
Procedural-related complications and severe adverse events
Time Frame: within 90 days
evaluate complications and any adverse events
within 90 days
Serious non-hemorrhagic adverse events
Time Frame: within 90 days
evaluate complications and any adverse events
within 90 days
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

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

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

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

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 (Actual)

March 16, 2021

Primary Completion (Anticipated)

May 16, 2024

Study Completion (Anticipated)

May 16, 2024

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

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

No

Studies a U.S. FDA-regulated device product

No

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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