Rescue Intracranial Stenting in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— RISIS  

Official title:

Rescue Intracranial Stenting in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986774
• Other study ID #: Can Tho SIS Hospital
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 29, 2021

Study information

• Verified date: September 2021
• Source: Can Tho Stroke International Services Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 29, 2021
• Est. primary completion date: May 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Atherosclerosis
• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Hemorrhage
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Intracranial Hemorrhages
• Ischemia
• Ischemic Stroke
• Stent Occlusion
• Stent Stenosis
• Stroke
• Stroke, Ischemic

Intervention

Procedure:
• Rescue intracranial stenting
Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Locations

Country	Name	City	State
Vietnam	Can Tho SIS Hospital	C?n Tho

Sponsors (1)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

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. — View 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. — View Citation

Pérez-García C, Gómez-Escalonilla C, Rosati S, López-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The "non-poor" 3-month outcome rate.	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).	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 rescue intracranial stenting.