Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Basilar Artery Occlusion Chinese Endovascular Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737189
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Zhangzhou Municipal Hospital of Fujian Province
The First People's Hospital of Changzhou
Xinqiao Hospital of Chongqing
Changhai Hospital
Baotou Central Hospital
The 101st Hospital of Chinese People's Liberation Army
Linyi People's Hospital
PLA 264 Hospital, Taiyuan, Shanxi
The First Affiliated Hospital with Nanjing Medical University
Tianjin TEDA Hospital
Liaocheng People's Hospital
Luoyang Central Hospital
Subei People's Hospital of Jiangsu Province
PLA 148 Hospital, Zibo, Shandong
Hebei General Hospital
Shengli Oilfield Hospital
Shenzhen Bao'an District People's Hospital
First Hospital of Jilin University
Henan Provincial Hospital
Peking University Binhai Hospital
Beijing Tiantan Hospital
The Military General Hospital of Beijing, PLA
The First Affiliated Hospital of Shanxi Medical University
Beijing Luhe Hospital
Nantong University
The Affiliated Hospital Of Guizhou Medical University
Nanning Second People's Hospital
Chongqing Three Gorges Central Hospital
The First Affiliated Hospital of Dalian Medical University
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief 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.

Condition or disease Intervention/treatment Phase
Basilar Artery Occlusion Ischemic Stroke Cerebrovascular Disorders Procedure: Mechanical embolectomy Drug: Medical Treatment Not Applicable

Detailed Description:

Study Objective: To evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving meaningful outcomes (better than death or equivalent) defined as modified Rankin score (mRS) 0-4 at 90 days in subjects presenting with ischemic stroke due to basilar artery occlusion up to 24 hours from symptom onset.

Subject Population: Subjects presenting with acute ischemic stroke within 6-24 hours from symptom onset/last seen well and whose strokes are attributable to an occlusion of the basilar artery. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. The randomization employs a 1:1 ratio of mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration versus medical management alone. Randomization will be done under a stratification process using age, baseline National Institute of Health Stroke Scale (NIHSS) and therapeutic window. For the primary endpoint, subjects will be followed for 90 days post-randomization.Sample size is projected to be 318 patients.

Care providers: Vascular neurologists and trained interventional neuroradiologists or neurologists in certified comprehensive stroke centers that treat more than 500 acute stroke patients and perform more than 30 acute mechanical thrombectomies every year will treat patients. Neurointerventionalists have to have previously performed at least 10 thrombectomies with Solitaire device in acute ischemic stroke patients.

Interventions: Patients in both arms will be admitted at acute stroke units (or Intensive Care Unit if needed) and treated following the Chinese Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Concomitant medications and non-pharmacological therapies will be recorded. If a decision of stopping support life measures is adopted, this will be recorded in the Case Report Form (CRF).A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion angioplasty/stenting through detachment of the Solitaire device will be allowed.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Revascularization With Solitaire Stentriever Versus Best Medical Therapy in the Treatment of Acute Ischemic Stroke Due to Basilar Artery Occlusion Presenting Within 6-24 Hours of Symptom Onset
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Endovascular Arm

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

Best Medical Treatment and maximum supportive care

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

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




Primary Outcome Measures :
  1. Proportion of patients achieving meaningful outcomes [ Time Frame: 90 days ]
    The primary objective of this study is to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving meaningful outcomes (better than death or equivalent) (mRS ≤ 4) at 90 days in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.


Secondary Outcome Measures :
  1. Primary endpoint at one year [ Time Frame: 1 year ]
    Proportion of patients achieving meaningful outcomes defined as mRS 0-4

  2. Dichotomized mRS score (0-2 versus 3-6) [ Time Frame: 90 days ]
  3. Dramatic early favorable response [ Time Frame: 24 hours ]
    Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12 hours) hours

  4. Final infarct volume and the change of infarct volume compared with baseline [ Time Frame: 24 hours (-2/+12 hours) ]
    Infarct volume evaluated on Computed Tomography (CT) or Magnetic Resonance (MR) at 24 hours (-2/+12 hours)

  5. Vessel recanalization with Arterial Occlusive Lesion (AOL) grades [ Time Frame: 24 hours (-2/+12 hours) ]
    Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades

  6. Modified Rankin Score (mRS) [ Time Frame: 90 days ]
  7. Barthel Index [ Time Frame: 90 days ]
  8. NIHSS [ Time Frame: 90 days ]
  9. Quality of life analysis [ Time Frame: 3 month, 6 months and 1 year ]
    Quality of life analysis as measured by EuroQol/EQ5D and SF-36 at 3 month, 6 months and 1 year, between interventional therapy vs medical therapy alone

  10. Mortality [ Time Frame: at 90 days ]
  11. Symptomatic intracranial hemorrhage (SICH) [ Time Frame: 24 (-2/+12) hours ]
  12. Serious Adverse Events [ Time Frame: 1 year ]
  13. Montreal Cognition Test (MOCA) [ Time Frame: 90 days ]
  14. Immediate Post-Endovascular Treatment Recanalization (for the Solitaire arm only) [ Time Frame: Immediate Post-Endovascular Treatment ]
    Successful recanalization is defined as TICI (Thrombolysis in Cerebral Infarction) 2b or 3 in the post-procedure angiography.

  15. Procedural related complications [ Time Frame: Perioperative period ]
    arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Posterior circulation AIS within 6-24 hours from symptom onset/last seen well where patient is ineligible for i.v. thrombolytic treatment, or patient has received i.v. thrombolytic therapy without recanalization.
  2. Occlusion (Thrombolysis in Myocardial Infarction, TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries as evidenced by computed tomography (CT) angiography, magnetic resonance (MR) angiography or angiogram.
  3. Age ≥18 and ≤80 years.
  4. Baseline National Institutes of Health Stroke Scale (NIHSS) score obtained prior to randomization must be equal to or higher than 10 points.
  5. No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
  6. Patient treatable within 24 hours from time last seen well. Isolated vertigo with nausea and/or vomiting is not considered onset of symptom.
  7. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion criteria

General Exclusion Criteria:

  1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio > 3.0.
  2. Baseline platelet count < 50.000/µL.
  3. Baseline blood glucose < 50mg/dL or > 400mg/dL.
  4. Severe, sustained hypertension (systolic blood pressure > 220 mm Hg or diastolic blood pressure > 110 mm Hg).
  5. Patients in sedation and/or intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
  6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
  7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
  8. History of life threatening allergy (more than rash) to contrast medium
  9. Subjects who has received i.v. tissue plasminogen activator (t-PA) treatment beyond 4.5 hours from the beginning of the symptoms.
  10. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery (beyond 48h they should be randomized in BAOCHE or excluded for endovascular treatment if poor medical conditions).
  11. Renal insufficiency with creatinine ≥ 3 mg/dl.
  12. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
  13. Subject participating in a study involving an investigational drug or device that would impact this study.
  14. Cerebral vasculitis.
  15. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations; mRS score at baseline must be ≤ 1.
  16. Unlikely to be available for 90 days follow-up.

Neuroimaging Exclusion Criteria:

  1. Hypodensity amounting to a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) < 6 and Pons-midbrain-index of ≥ 3 on CT angiography source images or MR with diffusion-weighted imaging.
  2. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
  3. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
  4. Complete unilateral or bilateral thalamic infarction on CT or MRI
  5. Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
  6. Subjects with occlusions in both anterior and posterior circulation.
  7. Evidence of intracranial tumor (except small meningioma).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737189


Contacts
Layout table for location contacts
Contact: Chuanhui Li, MD 15210439828 lichuanhui365@163.com

Locations
Layout table for location information
China
Baotou Central Hospital Recruiting
Baotou, China
Contact: Changchun Jiang         
Principal Investigator: Changchun Jiang         
Beijing Luhe Hospital Recruiting
Beijing, China
Contact: Xiaokun Geng         
Principal Investigator: Xiaokun Geng         
Beijing Tiantan Hospital Recruiting
Beijing, China
Contact: Zhongrong Miao         
Principal Investigator: Zhongrong Miao         
The Military General Hospital of Beijing, PLA Recruiting
Beijing, China
Contact: Qiang Zhang         
Principal Investigator: Qiang Zhang         
Xuanwu Hospital Recruiting
Beijing, China
Contact: Chuanhui Li         
Contact: Ming Ren         
Principal Investigator: Jian Chen         
Sub-Investigator: Chuanhui Li         
The First People's Hospital of Changzhou Recruiting
Changzhou, China
Contact: Ya Peng         
Principal Investigator: Ya Peng         
Chongqing Three Gorges Central Hospital Recruiting
Chongqing, China
Contact: Shengli Chen         
Principal Investigator: Shengli Chen         
Xinqiao Hospital of Chongqing Not yet recruiting
Chongqing, China
Contact: Qingwu Yang         
Principal Investigator: Qingwu Yang         
Shengli Oilfield Hospital Recruiting
Dongying, China
Contact: Zongen Gao         
Principal Investigator: Zongen Gao         
The Affiliated Hospital Of Guizhou Medical University Recruiting
Guiyang, China
Contact: Hua Yang         
Principal Investigator: Hua Yang         
First Hospital of Jilin University Recruiting
Jilin, China
Contact: Yi Yang         
Principal Investigator: Yi Yang         
Liaocheng Third People's Hospital Recruiting
Liaocheng, China
Contact: Cunfeng Song         
Principal Investigator: Cunfeng Song         
Linyi People's Hospital Recruiting
Linyi, China
Contact: Qiyi Zhu         
Principal Investigator: Qiyi Zhu         
Luoyang Central Hospital Recruiting
Luoyang, China
Contact: Liping Wei         
Principal Investigator: Liping Wei         
Nanjing First People's Hospital Not yet recruiting
Nanjing, China
Contact: Tong Li         
Principal Investigator: Tong Li         
The First Affiliated Hospital with Nanjing Medical University Not yet recruiting
Nanjing, China
Contact: Haibin Shi         
Principal Investigator: Haibin Shi         
Nanning Second People's Hospital Recruiting
Nanning, China
Contact: Tong Li         
Principal Investigator: Tong Li         
Nantong University Not yet recruiting
Nantong, China
Contact: Kaifu Ke         
Principal Investigator: Kaifu Ke         
Changhai Hospital Recruiting
Shanghai, China
Contact: Jianmin Liu         
Principal Investigator: Jianmin Liu         
Shenzhen Bao'an District People's Hospital Recruiting
Shenzhen, China
Contact: Huawei Ye         
Principal Investigator: Huawei Ye         
Hebei General Hospital Recruiting
Shijiazhuang, China
Contact: Fan Zhang         
Principal Investigator: Fan Zhang         
PLA 264 Hospital Recruiting
Taiyuan, China
Contact: Qingfeng Zhu         
Principal Investigator: Qingfeng Zhu         
The First Affiliated Hospital of Shanxi Medical University Recruiting
Taiyuan, China
Contact: Dong Kuai         
Principal Investigator: Dong Kuai         
Peking University Binhai Hospital Recruiting
Tianjin, China
Contact: Wanchao Shi         
Principal Investigator: Wanchao Shi         
Tianjin TEDA Hospital Recruiting
Tianjin, China
Contact: Zaiyu Guo         
Principal Investigator: Zaiyu Guo         
The 101st Hospital of Chinese People's Liberation Army Recruiting
Wuxi, China
Contact: Zhonghua Shi         
Principal Investigator: Zhonghua Shi         
Subei People's Hospital of Jiangsu Province Not yet recruiting
Yangzhou, China
Contact: Minghua Lv         
Principal Investigator: Minghua Lv         
Zhangzhou Municipal Hospital of Fujian Province Recruiting
Zhangzhou, China
Contact: Wenhuo Chen         
Principal Investigator: Wenhuo Chen         
Henan Provincial Hospital Recruiting
Zhengzhou, China
Contact: Liangfu Zhu         
Principal Investigator: Liangfu Zhu         
PLA 148 Hospital Recruiting
Zibo, China
Contact: Hui Zhang         
Principal Investigator: Hui Zhang         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Zhangzhou Municipal Hospital of Fujian Province
The First People's Hospital of Changzhou
Xinqiao Hospital of Chongqing
Changhai Hospital
Baotou Central Hospital
The 101st Hospital of Chinese People's Liberation Army
Linyi People's Hospital
PLA 264 Hospital, Taiyuan, Shanxi
The First Affiliated Hospital with Nanjing Medical University
Tianjin TEDA Hospital
Liaocheng People's Hospital
Luoyang Central Hospital
Subei People's Hospital of Jiangsu Province
PLA 148 Hospital, Zibo, Shandong
Hebei General Hospital
Shengli Oilfield Hospital
Shenzhen Bao'an District People's Hospital
First Hospital of Jilin University
Henan Provincial Hospital
Peking University Binhai Hospital
Beijing Tiantan Hospital
The Military General Hospital of Beijing, PLA
The First Affiliated Hospital of Shanxi Medical University
Beijing Luhe Hospital
Nantong University
The Affiliated Hospital Of Guizhou Medical University
Nanning Second People's Hospital
Chongqing Three Gorges Central Hospital
The First Affiliated Hospital of Dalian Medical University
Investigators
Layout table for investigator information
Principal Investigator: Xunming Ji, MD Xuanwu Hospital, Beijing
Principal Investigator: Tudor G Jovin, MD University of Pittsburg Medical Center Stroke

Publications:

Layout table for additonal information
Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02737189     History of Changes
Other Study ID Numbers: Xuanwu201601
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xuanwu Hospital, Beijing:
Basilar Artery Occlusion
Ischemic Stroke
Mechanical Embolectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Arterial Occlusive Diseases
Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes