Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke (TOESIS)

June 11, 2024 updated by: Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital

Tandem Occlusion After Emergent Stenting in Acute Ischemic Stroke: Preliminary Experience From a Vietnamese Comprehensive Stroke Centre

In acute ischemic stroke due to tandem occlusion, the emergent stenting has recently become an endovascular treatment option combining with mechanical thrombectomy to achieve recanalization. However, the data on the beneficial endovascular management of tandem occlusion in two circulations is still limited. The purpose of our study was to compare the improvement of clinical outcome between two circulations after emergent stenting at 3 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The posterior circulation (about 20 - 25%) is less frequent than the anterior one in the acute ischemic stroke, but high mortality and morbidity in the acute vertebrobasilar thrombosis even successful recanalization are revealed. Besides, tandem occlusion is one of the complex lesions in large vessel occlusions relating to the poor outcome, particularly in the posterior circulation. Recent studies have suggested that emergent stenting could be used as an additional treatment to achieve permanent recanalization together with mechanical thrombectomy in the intracranial segments. Permanent recanalization is one of the most important factors that impact patient outcomes after acute ischemic stroke. However, although there are various approaches for this lesion, the comparision of the effectiveness in the two circulations remains unclear. Thus, the aims of our study were to compare baseline characteristics and clinical outcome of tandem occlusions between anterior and posterior circulation after emergent stenting in extracranial arteries.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Can Tho Stroke International Services Hospital
  • Phone Number: +84886559911
  • Email: cskh@dotquy.vn

Study Locations

  • Vietnam
      • Can Tho, Vietnam, 900000
        • Recruiting
        • Can Tho Stroke International Services Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years old
  • Premorbid mRS < 2
  • NIHSS > 5
  • ASPECTS ≥ 5 or pc-ASPECTS ≥ 5

Exclusion Criteria:

  • Onset to treatment time > 24 hours
  • Loss to follow up after discharge

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emergent Stenting in Anterior circulation
Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions
Procedure: Emergent Stenting
Emergent Stenting in acute ischemic stroke caused by tandem occlusions
Other Names:
  • ES
Experimental: Emergent Stenting in Posterior circulation
Emergent Extracranial Vertebral Stenting in acute ischemic stroke caused by tandem occlusions
Procedure: Emergent Stenting
Emergent Stenting in acute ischemic stroke caused by tandem occlusions
Other Names:
  • ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The favorable 3-month outcome rate
Time Frame: 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).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The symptomatic intracerebral hemorrhage rate
Time Frame: 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 modified Rankin Score (mRS).
24 hours after emergent stenting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can Tho Stroke International Services Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOESIS Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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