Basilar Artery Occlusion Chinese Endovascular Trial

May 25, 2022 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Detailed Description

Study Objective: To evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving favourable outcomes defined as modified Rankin score (mRS) 0-3 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

Interventional

Enrollment (Actual)

217

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

      • Baotou, China
        • Baotou Central Hospital
      • Beijing, China
        • Xuanwu Hospital
      • Beijing, China
        • Beijing Luhe Hospital
      • Beijing, China
        • Beijing Tiantan Hospital
      • Beijing, China
        • The Military General Hospital of Beijing, PLA
      • Changzhou, China
        • The First People's Hospital of Changzhou
      • Chongqing, China
        • Xinqiao Hospital of Chongqing
      • Chongqing, China
        • Chongqing Three Gorges Central Hospital
      • Dongying, China
        • Shengli Oilfield Hospital
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
      • Jilin, China
        • First Hospital of Jilin University
      • Liaocheng, China
        • Liaocheng Third People's Hospital
      • Linyi, China
        • Linyi People's Hospital
      • Luoyang, China
        • Luoyang Central Hospital
      • Nanjing, China
        • Nanjing First People's Hospital
      • Nanjing, China
        • The First Affiliated Hospital with Nanjing Medical University
      • Nanning, China
        • Nanning Second People's Hospital
      • Nantong, China
        • Nantong University
      • Nanyang, China
        • Nanyang Central Hospital
      • Shanghai, China
        • Changhai Hospital
      • Shenzhen, China
        • Shenzhen Bao'an District People's Hospital
      • Shijiazhuang, China
        • Hebei General Hospital
      • Suzhou, China
        • Second Affiliated Hospital of Soochow University
      • Taiyuan, China
        • PLA 264 Hospital
      • Taiyuan, China
        • The First Affiliated Hospital of Shanxi Medical University
      • Tianjin, China
        • Tianjin TEDA Hospital
      • Tianjin, China
        • Peking University BinHai Hospital
      • Tianjin, China
        • The Fifth Central Hospital of Tianjin
      • Tianjin, China
        • Tianjin Huanhu Hospital
      • Wuxi, China
        • The 101st Hospital of Chinese People's Liberation Army
      • Xi'an, China
        • The Affiliated Hospital of Northwest University, Xi'an NO.3 Hospital
      • Yangzhou, China
        • Subei People's Hospital of Jiangsu province
      • Yantai, China
        • Yantaishan Hospital
      • Zhangzhou, China
        • Zhangzhou Municipal Hospital of Fujian Province
      • Zhengzhou, China
        • Henan Provincial Hospital
      • Zibo, China
        • PLA 148 Hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 6 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 or NCCT.
  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).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Arm

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

Best Medical Treatment and maximum supportive care

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Other: Control Arm
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients achieving favourable outcomes defined as mRS 0-3 at 90 days
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 favourable outcomes (mRS ≤ 3) 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dramatic early favorable response
Time Frame: 24 (-2/+12) 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.
24 (-2/+12) hours
Dichotomized mRS score (0-2 versus 3-6 and 0-4 versus 5-6 )
Time Frame: 90 days
90 days
Proportion of patients achieving meaningful outcomes defined as mRS 0-4 at 12 months.
Time Frame: 12 months
12 months
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)
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
24 hours (-2/+12 hours)
Modified Rankin Score (mRS)
Time Frame: 90 days
90 days
Barthel Index
Time Frame: 90 days
90 days
NIHSS
Time Frame: 90 days
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
3 month, 6 months and 1 year
Mortality
Time Frame: at 90 days
at 90 days
Symptomatic intracranial hemorrhage (SICH)
Time Frame: 24 (-2/+12) hours
24 (-2/+12) hours
Serious Adverse Events
Time Frame: 1 year
1 year
Montreal Cognition Test (MOCA)
Time Frame: 90 days
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.
Immediate Post-Endovascular Treatment
Procedural related complications
Time Frame: Perioperative period
arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on.
Perioperative period

Collaborators and Investigators

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

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.

General Publications

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

July 1, 2016

Primary Completion (Actual)

September 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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