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Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke

Primary Purpose

Stroke, Thrombectomy, Arterial Occlusive Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Double stentriever
Single stentriever
Sponsored by
Hospital Universitario Central de Asturias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Double Stentriever, Thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A new disabling focal neurological deficit compatible with acute cerebral ischemia. Any age. Informed consent obtained from the patient or representative. NIHSS score ≥ 6. Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale. Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography). ASPECTs score on baseline CT greater than or equal to 6. In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center. Exclusion Criteria: Those described in the usual protocols for mechanical thrombectomy of each hospital. Pre-existing functional clinical status greater than 2 according to the mRS clinical scale Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery. Initiation of treatment with a different technique than the one described. Inability to use a proximal balloon guide catheter. Use of aspiration catheter. Intracranial atherosclerotic plaque as the cause of occlusion. Advanced or terminal disease with a life expectancy of less than 6 months. Patient who is participating in another study that may affect this one. ASPECTS score less than or equal to 6 on baseline CT. Evidence of significant hemorrhage or mass effect with midline shift on baseline CT. Patients with occlusions in multiple vascular territories. Evidence of intracranial tumor (except for small meningiomas)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Double stentriever technique

    Single stentriever technique

    Arm Description

    Patients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm)

    Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).

    Outcomes

    Primary Outcome Measures

    EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass
    Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
    SAFETY OBJECTIVE: Intracerebral hemorrhage.
    Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4) at 24h observed between both groups and, fundamentally, evaluated by CT.

    Secondary Outcome Measures

    Intervention success.
    Rate of the ability to position both STs in the indicated location.
    Complications related to the intervention.
    Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.
    Embolism in new territories.
    Rate of embolization to an artery not involved in the initially affected territory.
    Number of passes with the devices.
    Evaluation of the number of passes with the devices during the procedure.
    Procedure time.
    Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention.
    Arterial Recanalization (eTICI scale) on first pass.
    evaluation of the rates of eTICI 3, eTICI 2c/3, eTICI e2b/3 on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
    Arterial recanalization at the end of the procedures.
    eTICI 3, eTICI e2c/3, eTICI e2b/3 at the end of the procedure on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
    Intracerebral hemorrhage.
    Rate of any type of intracranial hemorrhage on the 24-hour control computed tomography (CT) scan (subarachnoid hemorrhage and hemorrhage according to the classification used in the ECASS study).
    Early neurological improvement.
    Rate of patients with a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours. Improvement of Neurological status at 24 hours, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
    National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge.
    Neurological status at 24 hours, at day 5 (+/- 12 hours) or discharge, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
    Modified Rankin Scale (mRS) scale at 90 days.
    Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days
    Mortality rate.
    90-day mortality rate.

    Full Information

    First Posted
    June 24, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Hospital Universitario Central de Asturias
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05930145
    Brief Title
    Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke
    Official Title
    A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Central de Asturias

    4. Oversight

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

    5. Study Description

    Brief Summary
    Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.
    Detailed Description
    The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary. Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment. A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Thrombectomy, Arterial Occlusive Diseases
    Keywords
    Stroke, Double Stentriever, Thrombectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Patient & Outcomes adjudicator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Double stentriever technique
    Arm Type
    Experimental
    Arm Description
    Patients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm)
    Arm Title
    Single stentriever technique
    Arm Type
    Active Comparator
    Arm Description
    Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).
    Intervention Type
    Device
    Intervention Name(s)
    Double stentriever
    Intervention Description
    Double stentriever technique
    Intervention Type
    Device
    Intervention Name(s)
    Single stentriever
    Intervention Description
    Single stentriever technique
    Primary Outcome Measure Information:
    Title
    EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass
    Description
    Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
    Time Frame
    90 days
    Title
    SAFETY OBJECTIVE: Intracerebral hemorrhage.
    Description
    Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4) at 24h observed between both groups and, fundamentally, evaluated by CT.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Intervention success.
    Description
    Rate of the ability to position both STs in the indicated location.
    Time Frame
    During the procedure
    Title
    Complications related to the intervention.
    Description
    Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.
    Time Frame
    During the procedure
    Title
    Embolism in new territories.
    Description
    Rate of embolization to an artery not involved in the initially affected territory.
    Time Frame
    During the procedure
    Title
    Number of passes with the devices.
    Description
    Evaluation of the number of passes with the devices during the procedure.
    Time Frame
    During the procedure
    Title
    Procedure time.
    Description
    Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention.
    Time Frame
    During the procedure
    Title
    Arterial Recanalization (eTICI scale) on first pass.
    Description
    evaluation of the rates of eTICI 3, eTICI 2c/3, eTICI e2b/3 on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
    Time Frame
    During the procedure
    Title
    Arterial recanalization at the end of the procedures.
    Description
    eTICI 3, eTICI e2c/3, eTICI e2b/3 at the end of the procedure on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
    Time Frame
    During the procedure
    Title
    Intracerebral hemorrhage.
    Description
    Rate of any type of intracranial hemorrhage on the 24-hour control computed tomography (CT) scan (subarachnoid hemorrhage and hemorrhage according to the classification used in the ECASS study).
    Time Frame
    24 hours
    Title
    Early neurological improvement.
    Description
    Rate of patients with a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours. Improvement of Neurological status at 24 hours, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
    Time Frame
    24 hours
    Title
    National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge.
    Description
    Neurological status at 24 hours, at day 5 (+/- 12 hours) or discharge, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
    Time Frame
    5 days
    Title
    Modified Rankin Scale (mRS) scale at 90 days.
    Description
    Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days
    Time Frame
    90 days
    Title
    Mortality rate.
    Description
    90-day mortality rate.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A new disabling focal neurological deficit compatible with acute cerebral ischemia. Any age. Informed consent obtained from the patient or representative. NIHSS score ≥ 6. Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale. Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography). ASPECTs score on baseline CT greater than or equal to 6. In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center. Exclusion Criteria: Those described in the usual protocols for mechanical thrombectomy of each hospital. Pre-existing functional clinical status greater than 2 according to the mRS clinical scale Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery. Initiation of treatment with a different technique than the one described. Inability to use a proximal balloon guide catheter. Use of aspiration catheter. Intracranial atherosclerotic plaque as the cause of occlusion. Advanced or terminal disease with a life expectancy of less than 6 months. Patient who is participating in another study that may affect this one. ASPECTS score less than or equal to 6 on baseline CT. Evidence of significant hemorrhage or mass effect with midline shift on baseline CT. Patients with occlusions in multiple vascular territories. Evidence of intracranial tumor (except for small meningiomas)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    PEDRO VEGA VALDES, MD, PhD
    Phone
    0034985108000
    Ext
    39116
    Email
    peveval@yahoo.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35416489
    Citation
    Vega P, Murias E, Jimenez JM, Chaviano J, Rodriguez J, Calleja S, Delgado M, Benavente L, Castanon M, Puig J, Cigarran H, Arias F, Chapot R. First-line Double Stentriever Thrombectomy for M1/TICA Occlusions : Initial Experiences. Clin Neuroradiol. 2022 Dec;32(4):971-977. doi: 10.1007/s00062-022-01161-2. Epub 2022 Apr 13.
    Results Reference
    background
    PubMed Identifier
    36627194
    Citation
    Li J, Tiberi R, Canals P, Vargas D, Castano O, Molina M, Tomasello A, Ribo M. Double stent-retriever as the first-line approach in mechanical thrombectomy: a randomized in vitro evaluation. J Neurointerv Surg. 2023 Jan 10:jnis-2022-019887. doi: 10.1136/jnis-2022-019887. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    28366064
    Citation
    Okada H, Matsuda Y, Chung J, Crowley RW, Lopes DK. Utility of a Y-configured stentriever technique as a rescue method of thrombectomy for an intractable rooted thrombus located on the middle cerebral artery bifurcation: technical note. Neurosurg Focus. 2017 Apr;42(4):E17. doi: 10.3171/2017.1.FOCUS16511.
    Results Reference
    background
    PubMed Identifier
    34233944
    Citation
    Cabral LS, Mont'Alverne F, Silva HC, Passos Filho PE, Magalhaes PSC, Bianchin MM, Nogueira RG. Device size selection can enhance Y-stentrieving efficacy and safety as a rescue strategy in stroke thrombectomy. J Neurointerv Surg. 2022 Jun;14(6):558-563. doi: 10.1136/neurintsurg-2021-017751. Epub 2021 Jul 7.
    Results Reference
    background
    PubMed Identifier
    32973671
    Citation
    Li Z, Liu P, Zhang L, Zhang Y, Fang Y, Xing P, Huang Q, Yang P, Liu J. Y-Stent Rescue Technique for Failed Thrombectomy in Patients With Large Vessel Occlusion: A Case Series and Pooled Analysis. Front Neurol. 2020 Aug 27;11:924. doi: 10.3389/fneur.2020.00924. eCollection 2020.
    Results Reference
    background

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    Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke

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