Basilar Artery Occlusion Chinese Endovascular Trial

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Mechanical Embolectomy Procedure
    Intervention Desc: Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
    ARM 1: Kind: Experimental
    Label: Endovascular Arm
    Description: Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration Medical Treatment following Chinese Guidelines for the Early Management of Patients With Acute Ischemic Stroke
  • Medical treatment Drug
    Intervention Desc: Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
    ARM 1: Kind: Experimental
    Label: Endovascular Arm
    Description: Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration Medical Treatment following Chinese Guidelines for the Early Management of Patients With Acute Ischemic Stroke
    ARM 2: Kind: Experimental
    Label: Control Arm
    Description: Medical treatment following the Chinese Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients achieving meaningful outcomes 90 days No
Secondary Primary endpoint at one year 1 year No
Secondary Proportion of patients achieving favorable outcomes defined as mRS 0-2 90 days and 1 year No
Secondary Dramatic early favorable response 90 days No
Secondary Final infarct volume 24 hours (-2/+12 hours) No
Secondary Vessel recanalization with Thrombolysis in Myocardial Infarction (TIMI) grades 24 hours (-2/+12 hours) No
Secondary mRS difference at 90 days compare to each pre-visit 90 days No
Secondary Barthel Index 90 days No
Secondary NIHSS 90 days No
Secondary Quality of life analysis 3 month, 6 months and 1 year No
Secondary Mortality at 90 days Yes
Secondary Clinically significant intracerebral hemorrhage (ICH) rates 24 (-2/+12) hours Yes
Secondary Serious Adverse Events 1 year Yes
Secondary Vessel recanalization with Arterial Occlusive Lesion (AOL) grades 24 hours (-2/+12 hours) No
Secondary Modified Rankin Score (mRS) 90 days No
Secondary Symptomatic intracranial hemorrhage (SICH) 24 (-2/+12) hours Yes
Secondary Montreal Cognition Test (MOCA) 90 days No

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