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Rescue Intracranial Stenting in Acute Ischemic Stroke (RISIS)

Primary Purpose

Acute Stroke, Ischemic Stroke, Intracranial Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Rescue intracranial stenting
Sponsored by
Can Tho Stroke International Services Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Stroke focused on measuring Acute ischemic stroke, Rescue intracranial stenting, Symptomatic intracerebral hemorrhage, MRI 3 Tesla, Rehabilitation

Eligibility Criteria

20 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Can Tho SIS Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rescue Intracranial Stenting (RIS)

Arm Description

RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 11, 2021
Last Updated
September 3, 2021
Sponsor
Can Tho Stroke International Services Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04986774
Brief Title
Rescue Intracranial Stenting in Acute Ischemic Stroke
Acronym
RISIS
Official Title
Rescue Intracranial Stenting in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
May 29, 2021 (Actual)
Study Completion Date
August 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Can Tho Stroke International Services Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rescue Intracranial Stenting (RIS)
Arm Type
Experimental
Arm Description
RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion
Intervention Type
Procedure
Intervention Name(s)
Rescue intracranial stenting
Other Intervention Name(s)
RIS
Intervention Description
Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion
Primary Outcome Measure Information:
Title
The "non-poor" 3-month outcome rate.
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The symptomatic intracerebral hemorrhage rate.
Description
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.
Time Frame
24 hours after rescue intracranial stenting.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuong Tran Chi, Doctor
Organizational Affiliation
Can Tho SIS Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Can Tho SIS Hospital
City
Cần Thơ
ZIP/Postal Code
900000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32122218
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.
Results Reference
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PubMed Identifier
32607747
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.
Results Reference
background
PubMed Identifier
31125298
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.
Results Reference
background
PubMed Identifier
32117041
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.
Results Reference
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Rescue Intracranial Stenting in Acute Ischemic Stroke

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