Rescue Intracranial Stenting in Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Intracranial Hemorrhages; Thrombotic Stroke, Acute; Acute Stroke; Stent Stenosis; Cerebral Ischemia; Ischemic Stroke; Intracranial Atherosclerosis; Stent Occlusion; Stroke, Ischemic
• Interventions: Procedure: Rescue intracranial stenting

• Registration Number: NCT04986774
• Lead Sponsor: Can Tho Stroke International Services Hospital

Brief Summary

In acute ischemic stroke caused by intracranial large vessel occlusion, rescue intracranial stenting has been recently a treatment option to achieve recanalization in patients with the failure of mechanical thrombectomy. Nevertheless, there are few studies supporting this beneficial treatment in two cerebral circulations. We aimed to analyse whether the use of rescue intracranial stenting would improve prognosis of patients at 3 months.

Detailed Description

In Asia population, large intracranial arterial stenosis lesion accounts for more than 30% in common causes of ischemic stroke, compares with about 10% in Caucasian population every year. Normally, in human brain, there are about 130 billion neurons but they are lost equivalent to their losses in approximately 3.6 years of normal aging in case of a large vessel ischemic stroke untreated each hour. Consequently, after the success of 5 randomized controlled trials about the mechanical thrombectomy, which have been done from December 2010 to December 2014, all of guidelines recommended this technique as the first-line treatment in acute ischemic stroke. However, the HERMES meta-analysis showed that revascularisation failure ratio 28.9% in patients older than 80 years. Recently, in case of mechanical thrombectomy failure, many studies suggested the rescue intracranial stenting could be alternative urgently needed treatment to achieve permanent recanalization which is one of the most important factors impacting on clinical outcomes after acute ischemic stroke. Hence, the aims of our study were to assess both the "non-poor" outcome at 3 months and the symptomatic intracerebral hemorrhage relating to procedure in patients receiving rescue intracranial stenting.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2021-05-29
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-31
• Study First Posted: 2021-08-03
• Study Completion: 2021-08-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Evidence of intracranial large vessel occlusion.
• Absence of intracranial hemorrhage.
• Severe stenosis or reocclusion after mechanical thrombectomy.

Exclusion Criteria

• Tandem lesion.
• Loss to follow-up after discharge.
• A severe or fatal combined illness before acute ischemic stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rescue Intracranial Stenting (RIS)	Rescue intracranial stenting	RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Primary Outcome Measures

Name	Time	Method
The "non-poor" 3-month outcome rate.	3 months	The "non-poor" 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

Name	Time	Method
The symptomatic intracerebral hemorrhage rate.	24 hours after rescue intracranial 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.

Trial Locations

Locations (1)

Can Tho SIS Hospital; 🇻🇳 Cần Thơ, Vietnam