Basilar Artery Occlusion Chinese Endovascular Trial

Summary

Endovascular treatment of acute ischemic stroke has shown strong benefit in several prospective randomized trials in the anterior circulation and endovascular therapy for basilar artery occlusion has shown promising results in several single-arm studies. This has led to a broad adoption of these techniques which are now considered standard of care in many institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates of symptomatic intracerebral hemorrhage in these studies have consistently been around 5% which raises the question as to whether patients could actually be harmed as opposed to helped by these procedures. This is a prospective, multi-center, randomized, controlled, open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.

Conditions

• Basilar Artery Occlusion
• Ischemic Stroke
• Cerebrovascular Disorders

Interventions

PROCEDURE

Mechanical embolectomy

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

DRUG

Medical Treatment

Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment

Sponsors & Collaborators

• Zhangzhou Municipal Hospital of Fujian Province

  collaborator OTHER

• The First People's Hospital of Changzhou

  collaborator OTHER

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Baotou Central Hospital

  collaborator OTHER

• 904th Hospital of the Joint Logistics Support Force of the PLA

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• The 985 Hospital of PLA, Taiyuan, Shanxi

  collaborator UNKNOWN

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Tianjin TEDA Hospital

  collaborator UNKNOWN

• Liaocheng People's Hospital

  collaborator OTHER

• Luoyang Central Hospital

  collaborator OTHER

• Subei People's Hospital of Jiangsu Province

  collaborator OTHER

• PLA 148 Hospital, Zibo, Shandong

  collaborator UNKNOWN

• Hebei General Hospital

  collaborator OTHER

• Shengli Oilfield Hospital

  collaborator OTHER

• Shenzhen Bao'an District People's Hospital

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Peking University Binhai Hospital

  collaborator UNKNOWN

• Beijing Tiantan Hospital

  collaborator OTHER

• The Military General Hospital of Beijing, PLA

  collaborator UNKNOWN

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Beijing Luhe Hospital

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Nanning Second People's Hospital

  collaborator OTHER

• Chongqing Three Gorges Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The Fifth Central Hospital of Tianjin，TianJin

  collaborator UNKNOWN

• Yantaishan Hospital

  collaborator UNKNOWN

• Nanyang Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Tianjin Huanhu Hospital

  collaborator OTHER

• The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital

  collaborator UNKNOWN

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Xunming Ji, MD · Xuanwu Hospital, Beijing

• Tudor G Jovin, MD · University of Pittsburg Medical Center Stroke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2021-09-30

Completion

2022-06-30

Countries

• China

Study Locations