NCT04743076

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

February 2, 2021

Last Update Submit

September 7, 2021

Conditions

Vertebrobasilar Stroke

Keywords

endovascular treatmentthrombolysis

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin scale score

    disability level

    90 days

Secondary Outcomes (11)

  • Rate of a score of 0~2 on modified Rankin scale

    90 days

  • Improvement in NIHSS between baseline and 24 hours

    at 24 hours from randomization

  • Improvement in NIHSS between baseline and 5~7d

    at 5~7 days from randomization

  • Improvement in GCS between baseline and 24 hours

    at 24 hours from randomization

  • Improvement in GCS between baseline and 24 hours

    at 5~7 days from randomization

  • +6 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Standard medical treatment plus endovascular treatment

Procedure: Endovascular treatmentOther: Standard medical treatment

Control group

ACTIVE COMPARATOR

Standard medical treatment alone

Other: Standard medical treatment

Interventions

Endovascular treatmentPROCEDURE

Endovascular treatment

Intervention group
Standard medical treatmentOTHER

Standard medical treatment

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

Location

Banan District People's Hospital

Banan, Chongqing Municipality, 400040, China

Location

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Wuyi Traditional Chinese Medicine Hospital

Jiangmen, Guangdong, 529000, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, 529030, China

Location

Maoming Traditional Chinese Medicine Hospital

Maoming, Guangdong, 525000, China

Location

Chinese Medical Hospital of Zhongshan

Zhongshan, Guangdong, 528400, China

Location

The 924th Hospital of CPLA

Guilin, Guangxi, 541000, China

Location

Danzhai People's Hospital

Longquan, Guizhou, 557500, China

Location

Nanyang Central Hospital

Nanyang, Henan, 473000, China

Location

Wuhan No. 1 Hospital

Wuhan, Hubei, 430000, China

Location

The 904th Hospital of CPLA

Wuxi, Jiangsu, 214000, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

Location

The First Affiliated Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Related Publications (1)

  • 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.

    PMID: 32080711RESULT

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 8, 2021

Study Start

March 16, 2021

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

study data without patient information

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Related papers published 3 months later, the IPD will be shared
Access Criteria
yangqwmlys@163.com ziwenjie1981@163.com

Locations

CN(16)