ECSIS: Emergent Carotid Stenting in Acute Ischemic Stroke

• Sponsor: Can Tho Stroke International Services Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06120218
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 50.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke; Ischemic Stroke, Acute; Carotid Stenosis	Procedure: Emergent Carotid Stenting	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Emergent Carotid Stenting in Acute Ischemic Stroke
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Nov 30, 2024
• Anticipated Study Completion Date: Feb 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emergent Carotid Stenting (ECS) Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions	Procedure: Emergent Carotid Stenting; Emergent Carotid Stenting in acute ischemic stroke caused by tandem occlusions; Other Names: ECS

Outcome Measures

Primary Outcome Measures

1. The favorable 3-month outcome rate [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).

Secondary Outcome Measures

1. The symptomatic intracerebral hemorrhage rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Can Tho Stroke International Services Hospital	Can Tho		Vietnam	900000

Sponsors and Collaborators

• Can Tho Stroke International Services Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dr. Cuong Tran Chi, Director, Can Tho Stroke International Services Hospital
• ClinicalTrials.gov Identifier: NCT06120218
• Other Study ID Numbers: ECSIS Study
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 10, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Cuong Tran Chi, Director, Can Tho Stroke International Services Hospital: internal carotid artery; acute ischemic stroke; stenting; tandem occlusions
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Carotid Stenosis; Ischemia

Study Results

No Results Posted as of Nov 10, 2023