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Basilar Artery Occlusion Chinese Endovascular Trial

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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 People's 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

Tracking Information
First Submitted Date  ICMJE March 6, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date June 25, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
  • Primary endpoint at one year [ Time Frame: 1 year ]
    Proportion of patients achieving meaningful outcomes defined as mRS 0-4
  • Dichotomized mRS score (0-2 versus 3-6) [ Time Frame: 90 days ]
  • 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
  • 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)
  • 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
  • Modified Rankin Score (mRS) [ Time Frame: 90 days ]
  • Barthel Index [ Time Frame: 90 days ]
  • NIHSS [ Time Frame: 90 days ]
  • 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
  • Mortality [ Time Frame: at 90 days ]
  • Symptomatic intracranial hemorrhage (SICH) [ Time Frame: 24 (-2/+12) hours ]
  • Serious Adverse Events [ Time Frame: 1 year ]
  • Montreal Cognition Test (MOCA) [ Time Frame: 90 days ]
  • 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.
  • Procedural related complications [ Time Frame: Perioperative period ]
    arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Primary endpoint at one year [ Time Frame: 1 year ]
    Proportion of patients achieving meaningful outcomes defined as mRS 0-4
  • Proportion of patients achieving favorable outcomes defined as mRS 0-2 [ Time Frame: 90 days and 1 year ]
  • Dramatic early favorable response [ Time Frame: 90 days ]
    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
  • Final infarct volume [ Time Frame: 24 hours (-2/+12 hours) ]
    Infarct volume evaluated on Computed Tomography (CT) or Magnetic Resonance (MR) at 24 hours (-2/+12 hours)
  • Vessel recanalization with Thrombolysis in Myocardial Infarction (TIMI) grades [ Time Frame: 24 hours (-2/+12 hours) ]
    Vessel recanalization evaluated by CT angiography (CTA) or MR Angiography (MRA) at 24 hours (-2/+12 hours) in both treatment groups as TIMI grades classified by a central Core-Lab.
  • mRS difference at 90 days compare to each pre-visit [ Time Frame: 90 days ]
    mRS difference at 90 days compare to that at baseline, at 5±2 days post procedure separately.
  • Barthel Index [ Time Frame: 90 days ]
  • NIHSS [ Time Frame: 90 days ]
  • Quality of life analysis [ Time Frame: 3 month, 6 months and 1 year ]
    Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and 1 year, between interventional therapy vs medical therapy alone
  • Mortality [ Time Frame: at 90 days ]
  • Clinically significant intracerebral hemorrhage (ICH) rates [ Time Frame: 24 (-2/+12) hours ]
    Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic ICH will be defined as per the SITS-MOST definition: evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans, combined with a deterioration in NIHSS score of ≥4 points or leading to death.
  • Serious Adverse Events [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basilar Artery Occlusion Chinese Endovascular Trial
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Basilar Artery Occlusion
  • Ischemic Stroke
  • Cerebrovascular Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Endovascular Arm

    Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

    Best Medical Treatment and maximum supportive care

    Interventions:
    • Procedure: Mechanical embolectomy
    • Drug: Medical Treatment
  • Control Arm
    Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
    Intervention: Drug: Medical Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
318
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chuanhui Li, MD 15210439828 lichuanhui365@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737189
Other Study ID Numbers  ICMJE Xuanwu201601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Collaborators  ICMJE
  • 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 People's 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  ICMJE
Principal Investigator: Xunming Ji, MD Xuanwu Hospital, Beijing
Principal Investigator: Tudor G Jovin, MD University of Pittsburg Medical Center Stroke
PRS Account Xuanwu Hospital, Beijing
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP