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Completed

NCT Number: NCT04986774

Rescue Intracranial Stenting in Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Stroke Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Ischemia Cerebrovascular Disorders Hemorrhage Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Atherosclerosis Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stent Occlusion Stent Stenosis Stroke Stroke, Ischemic Thrombotic Stroke Thrombotic Stroke, Acute Vascular Diseases

Age range

20 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rescue intracranial stenting

Procedure

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

Other names: RIS

Primary outcomes

  1. The "non-poor" 3-month outcome rate.

    Time frame: 3 months

    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 outcomes

  1. The symptomatic intracerebral hemorrhage rate.

    Time frame: 24 hours after rescue intracranial stenting.

    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.

Sponsors and collaborators

Lead sponsor

Can Tho Stroke International Services Hospital

Other

Registry information

Acronym: RISIS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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