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CompletedNCT04986774RISISUpdated Sep 13, 2021

Rescue Intracranial Stenting in Acute Ischemic Stroke

An interventional study of Rescue intracranial stenting in Acute Stroke, Ischemic Stroke and Intracranial Atherosclerosis, sponsored by Can Tho Stroke International Services Hospital. Completed at 1 site in Vietnam. Open to participants aged 20 Years to 105 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Can Tho Stroke International Services Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
20 Years to 105 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
20 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Tandem lesion.
  • Loss to follow-up after discharge.
  • A severe or fatal combined illness before acute ischemic stroke.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Rescue Intracranial Stenting (RIS)

    RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion

    Procedure: Rescue intracranial stenting

Interventions

  • ProcedureRescue intracranial stenting

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

    Also known as: RIS

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 24 hours after rescue intracranial stenting.

06

Study locations

1 site
  • Can Tho SIS Hospital
    Cần Thơ, 900000, Vietnam
07

References and documents

Publications

  • 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. PubMed 32122218 ↗
  • 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. PubMed 32607747 ↗
  • 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. PubMed 31125298 ↗
  • 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. PubMed 32117041 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04986774
Lead sponsor
Can Tho Stroke International Services Hospital
Responsible party
Dr. Cuong Tran Chi (Director - Doctor, Can Tho Stroke International Services Hospital) — Principal investigator
First posted
Aug 3, 2021
Start date
Aug 1, 2019
Primary completion
May 29, 2021
Completion
Aug 29, 2021
Last update
Sep 13, 2021

Study contacts

Cuong Tran Chi, Doctor
study chair · Can Tho SIS Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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