Emergent Stenting In Acute Vertebrobasilar Occlusions

Acute Stroke Clinical Trial

— ESVO  

Official title:

Emergent Stenting In Acute Vertebrobasilar Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129721
• Other study ID #: ESVO Study
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 16, 2024

Study information

• Verified date: February 2024
• Source: Can Tho Stroke International Services Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 16, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Ischemia
• Ischemic Stroke
• Stroke
• Vertebrobasilar Insufficiency

Intervention

Procedure:
• Emergent Stenting
Emergent Stenting In Acute Vertebrobasilar Occlusions

Locations

Country	Name	City	State
Vietnam	Can Tho Stroke International Services Hospital	Can Tho

Sponsors (1)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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