NCT06129721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

November 8, 2023

Last Update Submit

February 29, 2024

Conditions

Keywords

vertebrobasilar occlusionsacute ischemic strokeemerging stenting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The symptomatic intracerebral hemorrhage rate

    24 hours after emergent stenting

Study Arms (1)

Emergent Stenting

EXPERIMENTAL

Emergent Stenting In Acute Vertebrobasilar Occlusions

Procedure: Emergent Stenting

Interventions

Emergent Stenting In Acute Vertebrobasilar Occlusions

Also known as: ES
Emergent Stenting

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho Stroke International Services Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (2)

  • 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.

    PMID: 36263574BACKGROUND
  • 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.

    PMID: 36591828BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeVertebrobasilar Insufficiency

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Cuong Tran Chi, Doctor

    Can Tho Stroke International Services General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

December 1, 2020

Primary Completion

January 5, 2024

Study Completion

February 16, 2024

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations