ESVO: Emergent Stenting In Acute Vertebrobasilar Occlusions

Sponsor
Can Tho Stroke International Services Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06129721
Collaborator
(none)
80
1
1
42.9
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Emergent Stenting
N/A

Detailed Description

Acute ischemic stroke in posterior circulation account for nearly 20 - 25%, in which large vessel occlusions (LVOs) occur 0.8% - 5.7% of two circulation strokes. 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 emergent stenting for acute vertebrobasilar occlusions stroke in order to support the successful recanalization in the setting of failure of mechanical thrombectomy. Moreover, the successful recanalization is one of the independent predictors of favorable outcomes. However, the use of the loading dose dual antiplatelet therapy and peri-procedural complications made the safety of emergent stenting remain uncertain. Therefore, the investigators aimed to investigate the impact of emergent stenting on the improved recanalization and clinical outcome in vertebrobasilar occlusions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Emergent Stenting In Acute Vertebrobasilar Occlusions
Actual Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Emergent Stenting

Emergent Stenting In Acute Vertebrobasilar Occlusions

Procedure: Emergent Stenting
Emergent Stenting In Acute Vertebrobasilar Occlusions
Other Names:
  • ES
  • Outcome Measures

    Primary Outcome Measures

    1. The favorable 3-month outcome rate [3 months]

      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).

    Secondary Outcome Measures

    1. The symptomatic intracerebral hemorrhage rate [24 hours after emergent stenting]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age > 18 years old

    • Onset to treatment time < 24 hours

    • NIHSS ≥ 6

    Exclusion Criteria:
    • Premorbid mRS > 2

    • Loss to follow up after discharge

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Can Tho Stroke International Services Hospital Can Tho Vietnam 900000

    Sponsors and Collaborators

    • Can Tho Stroke International Services Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Cuong Tran Chi, Director, Can Tho Stroke International Services Hospital
    ClinicalTrials.gov Identifier:
    NCT06129721
    Other Study ID Numbers:
    • ESVO Study
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Cuong Tran Chi, Director, Can Tho Stroke International Services Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023