Emergent Stenting In Acute Vertebrobasilar Occlusions

NCT ID: NCT06129721

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-02-16

Brief 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.

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.

Conditions

Acute Stroke; Ischemic Stroke, Acute; Vertebro Basilar Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emergent Stenting

Emergent Stenting In Acute Vertebrobasilar Occlusions

Group Type: EXPERIMENTAL

Emergent Stenting

Intervention Type: PROCEDURE

Emergent Stenting In Acute Vertebrobasilar Occlusions

Interventions

Emergent Stenting

Emergent Stenting In Acute Vertebrobasilar Occlusions

Intervention Type: PROCEDURE

Other Intervention Names

ES

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Can Tho Stroke International Services Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Cuong Tran Chi

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cuong Tran Chi, Doctor

Role: STUDY_DIRECTOR

Can Tho Stroke International Services General Hospital

Locations

Can Tho Stroke International Services Hospital

Can Tho, , Vietnam

Countries

Vietnam

References

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.

Reference Type: BACKGROUND

PMID: 36263574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36591828 (View on PubMed)

Other Identifiers

ESVO Study

Identifier Type: -

Identifier Source: org_study_id