Tandem Occlusions After Emergent Stenting in Acute Ischemic Stroke

Acute Stroke Clinical Trial

— TOESIS  

Official title:

Tandem Occlusions After Emergent Stenting in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120218
• Other study ID #: TOESIS Study
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 28, 2025

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

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 (3)

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

Anadani M, Marnat G, Consoli A, Papanagiotou P, Nogueira RG, Siddiqui A, Ribo M, Spiotta AM, Bourcier R, Kyheng M, Labreuche J, de Havenon A, Sibon I, Dargazanli C, Arquizan C, Cognard C, Olivot JM, Anxionnat R, Audibert G, Mazighi M, Blanc R, Lapergue B, Richard S, Gory B; TITAN and ETIS Registry Investigators. Endovascular Therapy of Anterior Circulation Tandem Occlusions: Pooled Analysis From the TITAN and ETIS Registries. Stroke. 2021 Oct;52(10):3097-3105. doi: 10.1161/STROKEAHA.120.033032. Epub 2021 Aug 10. — View Citation

Jadhav AP, Zaidat OO, Liebeskind DS, Yavagal DR, Haussen DC, Hellinger FR Jr, Jahan R, Jumaa MA, Szeder V, Nogueira RG, Jovin TG. Emergent Management of Tandem Lesions in Acute Ischemic Stroke. Stroke. 2019 Feb;50(2):428-433. doi: 10.1161/STROKEAHA.118.021893. — 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 mRS.	24 hours after emergent carotid stenting