Emergent Stenting In Acute Vertebrobasilar Occlusions (ESVO)

In the acute posterior circulation strokes, the vertebrobasilar occlusions frequently related to worse outcomes than the anterior ones. However, few studies mentioned the benefit and safety of the emergent stenting in the successful recanalization at these complex occlusions. The investigators investigated whether the improvement of clinical outcome was achieved in postprocedural 3-month.

Study Overview

• Status: Completed
• Conditions: Acute Stroke; Ischemic Stroke, Acute; Vertebro Basilar Ischemia
• Intervention / Treatment: Procedure: Emergent Stenting

Detailed Description

Acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (LVOs) occur 0.8% - 5.7%. Although mechanical thrombectomy (MT) has recently been the gold standard in LVOs treatment, the futile recanalization (defined as unfavorable outcome despite early successful recanalization of target artery) rate was showed in posterior circulation higher than in anterior one. Multiple randomized controlled trials (BEST, BASICS, BAOCHE, ATTENTION) have recently reported the benefit of endovascular treatment better than of standard medical treatment for acute vertebrobasilar occlusions stroke. Besides, up to 36% LVOs with underlying intracranial stenosis and 64% with tandem lesions occured in the acute vertebrobasilar stroke. This was a reason why emergent stenting was considered to support the successful recanalization in the setting of failure of mechanical thrombectomy. Moreover, the successful recanalization is one of the independent predictors of good outcomes. However, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. Therefore, we aimed to investigate whether the impact of emergent stenting on the improved clinical outcome in vertebrobasilar occlusions.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Can Tho, Vietnam, 900000
    • Can Tho Stroke International Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18 years old
• Onset to treatment time < 24 hours
• NIHSS ≥ 10
• pc-ASPECTS ≥ 5 on MRI

Exclusion Criteria:

• Premorbid mRS > 2
• Extensive, bilateral brain-stem infarction on neuroimaging
• Cerebellar mass effect on neuroimaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emergent Stenting; Emergent Stenting In Acute Vertebrobasilar Occlusions	Procedure: Emergent Stenting; Emergent Stenting In Acute Vertebrobasilar Occlusions; Other Names: ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The favorable 3-month outcome rate	The favorable 3-month outcome rate was accessed by modified Rankin Score (mRS), which comprised of included good (mRS 0 - ≤ 2) and fair (mRS 3).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The symptomatic intracerebral hemorrhage rate	The symptomatic intracerebral hemorrhage was defined as patient's intracerebral hemorrhage with postprocedural mRS ≥ 5 and there were no other evident causes for the increased mRS	24 hours after emergent stenting

Collaborators and Investigators

• Sponsor: Can Tho Stroke International Services Hospital
• Investigators: Study Director: Cuong Tran Chi, Doctor, Can Tho Stroke International Services General Hospital

Publications and helpful links

General Publications

• Tran CC, Le MT, Baxter BW, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue intracranial stenting in acute ischemic stroke: a preliminary Vietnamese study. Eur Rev Med Pharmacol Sci. 2022 Oct;26(19):6944-6952. doi: 10.26355/eurrev_202210_29875.
• Le MT, Tran CC, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue stenting after the failure of intravenous thrombolysis and bridging thrombolysis: an initial Vietnamese report. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9162-9169. doi: 10.26355/eurrev_202212_30667.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: acute ischemic stroke; vertebrobasilar occlusions; emerging stenting
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Vertebrobasilar Insufficiency
• Other Study ID Numbers: ESVO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No