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

February 16, 2024 updated by: Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital
The successful recanalization is the essential standard for the tandem lesions in acute anterior ischemic stroke. However, one of the common complications after emergent carotid stenting is hemorrhagic transformation that makes the effect of this method controversial. The investigators investigated whether emergent carotid stenting achieved the improvement of clinical outcome in acute large vessel occlusion stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tandem occlusions estimated from 10% to 30% in acute anterior circulation ischemic stroke. These acute lesions had a worse prognosis with mortality rate about 50%, if the aggresive medical treatment, even intravenous thrombolysis alone was the first choice. The HERMES meta-analysis involving in mechanical thrombectomy from individual data of 5 randomized controlled trials showed benefit of mechanical thrombectomy of 122 tandem occlusions compared with medical management alone, but the endovascular treatment methods are debatable between angioplasty versus stenting at proximal extracranial carotid occlusion after successful recanalization in the intracranial segments. Multiple studies recorded recently the emergent carotid stenting was the additional option to improve cerebral blood flow which associated to favorable outcomes after acute tandem occlusions. However, there was a lack of evidence for the benefit of emergent carotid stenting in tandem occlusions in Asia. Therefore, the investigators aimed in this study to access the favorable outcomes in case of tandem occlusions treated with this procedure.

Study Type

Interventional

Enrollment (Estimated)

90

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
  • Onset to treatment time < 24 hours
  • NIHSS ≥ 6

Exclusion Criteria:

  • Premorbid mRS > 2
  • 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emergent Stenting (ES)
Emergent 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 carotid 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.
24 hours after emergent carotid 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)

November 30, 2024

Study Completion (Estimated)

February 28, 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)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 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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