Clinical trial NCT04986774: Rescue Intracranial Stenting in Acute Ischemic Stroke
Official title: Rescue Intracranial Stenting in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Ischemic Stroke
Intracranial Atherosclerosis
Stent Stenosis
Cerebral Ischemia
Stent Occlusion
Stroke, Ischemic
Intracranial Hemorrhages
Thrombotic Stroke, Acute
Keywords: Acute ischemic stroke
Rescue intracranial stenting
Symptomatic intracerebral hemorrhage
MRI 3 Tesla
Rehabilitation
Lead sponsor: Can Tho Stroke International Services Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The "non-poor" 3-month outcome rate.
timeFrame: 3 months
Secondary outcomes:
measure: The symptomatic intracerebral hemorrhage rate.
timeFrame: 24 hours after rescue intracranial stenting.
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: Can Tho SIS Hospital
Study officials:
affiliation: Can Tho SIS Hospital
name: Cuong Tran Chi, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.