NCT06365294

Brief Summary

The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 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 31, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3.3 years

First QC Date

April 10, 2024

Last Update Submit

June 9, 2024

Conditions

Keywords

tandem occlusionsposterior circulationrescue extracrnial stenting

Outcome Measures

Primary Outcomes (1)

  • The good 3-month outcome rate

    The good 3-month outcome rate was accessed by modified Rankin Score (mRS ≤ 2).

    3 months

Study Arms (1)

Rescue extracranial vertebral stenting

EXPERIMENTAL

Rescue extracranial vertebral stenting in tandem occlusions

Procedure: Rescue extracranial stenting

Interventions

Rescue extracranial stenting in tandem occlusions

Rescue extracranial vertebral stenting

Eligibility Criteria

Age18 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 \> 5
  • pc-ASPECTS ≥ 5

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (2)

  • Cohen JE, Leker RR, Gomori JM, Eichel R, Rajz G, Moscovici S, Itshayek E. Emergent revascularization of acute tandem vertebrobasilar occlusions: Endovascular approaches and technical considerations-Confirming the role of vertebral artery ostium stenosis as a cause of vertebrobasilar stroke. J Clin Neurosci. 2016 Dec;34:70-76. doi: 10.1016/j.jocn.2016.05.005. Epub 2016 Aug 10.

    PMID: 27522497BACKGROUND
  • Han N, Ma L, Zhao L, Xu G, Jia Y, Wang H. The Dilator-Dotter technique can successfully treat tandem lesions of posterior circulation. Medicine (Baltimore). 2024 Jan 26;103(4):e37044. doi: 10.1097/MD.0000000000037044.

    PMID: 38277540BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeVertebrobasilar Insufficiency

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Can Tho Stroke International Services Hospital

    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
SPONSOR INVESTIGATOR
PI Title
Director - Doctor

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

December 31, 2020

Primary Completion

April 30, 2024

Study Completion

June 8, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations