Rescue Intracranial Stenting in Acute Ischemic Stroke

NCT ID: NCT04986774

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-08-29

Brief Summary

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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

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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.

Conditions

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Acute Stroke Ischemic Stroke Intracranial Atherosclerosis Stent Stenosis Cerebral Ischemia Stent Occlusion Stroke, Ischemic Intracranial Hemorrhages Thrombotic Stroke, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rescue Intracranial Stenting (RIS)

RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Group Type EXPERIMENTAL

Rescue intracranial stenting

Intervention Type PROCEDURE

Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Interventions

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Rescue intracranial stenting

Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Intervention Type PROCEDURE

Other Intervention Names

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RIS

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Can Tho Stroke International Services Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Cuong Tran Chi

Director - Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cuong Tran Chi, Doctor

Role: STUDY_CHAIR

Can Tho SIS Hospital

Locations

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Can Tho SIS Hospital

Can Tho, , Vietnam

Site Status

Countries

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Vietnam

References

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Stracke CP, Fiehler J, Meyer L, Thomalla G, Krause LU, Lowens S, Rothaupt J, Kim BM, Heo JH, Yeo LLL, Andersson T, Kabbasch C, Dorn F, Chapot R, Hanning U. Emergency Intracranial Stenting in Acute Stroke: Predictors for Poor Outcome and for Complications. J Am Heart Assoc. 2020 Mar 3;9(5):e012795. doi: 10.1161/JAHA.119.012795. Epub 2020 Mar 3.

Reference Type BACKGROUND
PMID: 32122218 (View on PubMed)

Perez-Garcia C, Gomez-Escalonilla C, Rosati S, Lopez-Ibor L, Egido JA, Simal P, Moreu M. Use of intracranial stent as rescue therapy after mechanical thrombectomy failure-9-year experience in a comprehensive stroke centre. Neuroradiology. 2020 Nov;62(11):1475-1483. doi: 10.1007/s00234-020-02487-9. Epub 2020 Jun 30.

Reference Type BACKGROUND
PMID: 32607747 (View on PubMed)

Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996.

Reference Type BACKGROUND
PMID: 31125298 (View on PubMed)

Meyer L, Fiehler J, Thomalla G, Krause LU, Lowens S, Rothaupt J, Kim BM, Heo JH, Yeo L, Andersson T, Kabbasch C, Dorn F, Chapot R, Stracke CP, Hanning U. Intracranial Stenting After Failed Thrombectomy in Patients With Moderately Severe Stroke: A Multicenter Cohort Study. Front Neurol. 2020 Feb 14;11:97. doi: 10.3389/fneur.2020.00097. eCollection 2020.

Reference Type BACKGROUND
PMID: 32117041 (View on PubMed)

Other Identifiers

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Can Tho SIS Hospital

Identifier Type: -

Identifier Source: org_study_id

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