CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 217 enrolled
Drug / intervention
Medical Treatment +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02737189
NCT02737189N/ACompleted

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

Xuanwu Hospital, Beijing·interventional·Posted Apr 13, 2016·Updated Jul 26, 2024

In Brief

A clinical study evaluating Mechanical embolectomy and Medical Treatment for Basilar Artery Occlusion and 2 related conditions. Completed, enrolled 217 participants across 36 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 13, 2016
Enrollment StartJul 1, 2016
Primary CompletionSep 1, 2021
Study CompletionJun 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.2 years ago

Interventions

Mechanical embolectomyprocedure

Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration

Medical Treatmentdrug

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