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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120218
Other study ID # TOESIS Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date November 30, 2025

Study information

Verified date June 2024
Source Can Tho Stroke International Services Hospital
Contact Cuong Tran Chi, Doctor
Phone +84886559911
Email drcuongtran@dotquy.vn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date November 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility 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 Design


Intervention

Procedure:
Emergent Stenting
Emergent Stenting in acute ischemic stroke caused by tandem occlusions

Locations

Country Name City State
Vietnam Can Tho Stroke International Services Hospital Can Tho

Sponsors (1)

Lead Sponsor Collaborator
Can Tho Stroke International Services Hospital

Country where clinical trial is conducted

Vietnam, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The symptomatic intracerebral hemorrhage rate 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
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