NCT04986774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

July 11, 2021

Last Update Submit

September 3, 2021

Conditions

Acute StrokeIschemic StrokeIntracranial AtherosclerosisStent StenosisCerebral IschemiaStent OcclusionStroke, IschemicIntracranial HemorrhagesThrombotic Stroke, Acute

Keywords

Acute ischemic strokeRescue intracranial stentingSymptomatic intracerebral hemorrhageMRI 3 TeslaRehabilitation

Outcome Measures

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).

    3 months

Secondary Outcomes (1)

  • The symptomatic intracerebral hemorrhage rate.

    24 hours after rescue intracranial stenting.

Study Arms (1)

Rescue Intracranial Stenting (RIS)

EXPERIMENTAL

RIS in Acute Ischemic Stroke caused by intracranial large vessel occlusion

Procedure: Rescue intracranial stenting

Interventions

Rescue intracranial stentingPROCEDURE

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

Also known as: RIS
Rescue Intracranial Stenting (RIS)

Eligibility Criteria

Age20 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (4)

  • 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.

    PMID: 32122218BACKGROUND

  • 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.

    PMID: 32607747BACKGROUND

  • 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.

    PMID: 31125298BACKGROUND

  • 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.

    PMID: 32117041BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeIntracranial ArteriosclerosisBrain IschemiaIntracranial HemorrhagesThrombotic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesArteriosclerosisArterial Occlusive DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cuong Tran Chi, Doctor

    Can Tho SIS Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - Doctor

Study Record Dates

First Submitted

July 11, 2021

First Posted

August 3, 2021

Study Start

August 1, 2019

Primary Completion

May 29, 2021

Study Completion

August 29, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)