NCT06120218

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

4.8 years

First QC Date

November 1, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

ThrombectomyExtracranial arteriesEndovascular treatmentAntegrade approachRetrograde approach

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 (2)

Emergent Stenting in Anterior circulation

EXPERIMENTAL

Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions

Procedure: Emergent Stenting

Emergent Stenting in Posterior circulation

EXPERIMENTAL

Emergent Extracranial Vertebral Stenting in acute ischemic stroke caused by tandem occlusions

Procedure: Emergent Stenting

Interventions

Emergent Stenting in acute ischemic stroke caused by tandem occlusions

Emergent Stenting in Anterior circulationEmergent Stenting in Posterior circulation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho Stroke International Services Hospital

Can Tho, 900000, Vietnam

RECRUITING

Related Publications (2)

  • Allard J, Delvoye F, Pop R, Labreuche J, Maier B, Marnat G, Sibon I, Zhu F, Lapergue B, Consoli A, Spelle L, Denier C, Richard S, Piotin M, Gory B, Mazighi M; ETIS Investigators. 24-Hour Carotid Stent Patency and Outcomes After Endovascular Therapy: A Multicenter Study. Stroke. 2023 Jan;54(1):124-131. doi: 10.1161/STROKEAHA.122.039797. Epub 2022 Dec 21.

    PMID: 36542074BACKGROUND
  • 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 Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cuong Tran Chi, Doctor

    Can Tho Stroke International Services General Hospital

    STUDY DIRECTOR

Central Study Contacts

Cuong Tran Chi, Doctor

CONTACT

Can Tho Stroke International Services Hospital

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

December 1, 2020

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations