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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
217
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
Baotou Central Hospital
Baotou, China
Beijing Luhe Hospital
Beijing, China
Beijing Tiantan Hospital
Beijing, China
The Military General Hospital of Beijing, PLA
Beijing, China
Xuanwu Hospital
Beijing, China
The First People's Hospital of Changzhou
proportion of patients achieving favourable outcomes defined as mRS 0-3 at 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.
Time frame: 90 days
Dramatic early favorable response
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.
Time frame: 24 (-2/+12) hours
Dichotomized mRS score (0-2 versus 3-6 and 0-4 versus 5-6 )
Time frame: 90 days
Proportion of patients achieving meaningful outcomes defined as mRS 0-4 at 12 months.
Time frame: 12 months
Final infarct volume and the change of infarct volume compared with baseline
Infarct volume evaluated on Computed Tomography (CT) or Magnetic Resonance (MR) at 24 hours (-2/+12 hours)
Time frame: 24 hours (-2/+12 hours)
Vessel recanalization with Arterial Occlusive Lesion (AOL) grades
Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades
Time frame: 24 hours (-2/+12 hours)
Modified Rankin Score (mRS)
Time frame: 90 days
Barthel Index
Time frame: 90 days
NIHSS
Time frame: 90 days
Quality of life analysis
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
Time frame: 3 month, 6 months and 1 year
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)
Successful recanalization is defined as TICI (Thrombolysis in Cerebral Infarction) 2b or 3 in the post-procedure angiography.
Time frame: Immediate Post-Endovascular Treatment
Procedural related complications
arterial perforation, arterial dissection, embolization in a previously uninvolved vascular territory and so on.
Time frame: Perioperative period
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Changzhou, China
Chongqing Three Gorges Central Hospital
Chongqing, China
Xinqiao Hospital of Chongqing
Chongqing, China
Shengli Oilfield Hospital
Dongying, China
The Affiliated Hospital Of Guizhou Medical University
Guiyang, China
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