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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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ClinicalTrials.gov Identifier: NCT05930145
Recruitment Status : Not yet recruiting
First Posted : July 5, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Pedro Vega Valdes, Hospital Universitario Central de Asturias

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Thrombectomy Arterial Occlusive Diseases Device: Double stentriever Device: Single stentriever Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Patient & Outcomes adjudicator
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Double stentriever technique
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)
 Device: Double stentriever
Double stentriever technique
Active Comparator: Single stentriever technique
Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).
 Device: Single stentriever
Single stentriever technique


Outcome Measures
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Primary Outcome Measures :
  1. EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass [ Time Frame: 90 days ]
    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).

  2. SAFETY OBJECTIVE: Intracerebral hemorrhage. [ Time Frame: 24 hours ]
    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 :
  1. Intervention success. [ Time Frame: During the procedure ]
    Rate of the ability to position both STs in the indicated location.

  2. Complications related to the intervention. [ Time Frame: During the procedure ]
    Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.

  3. Embolism in new territories. [ Time Frame: During the procedure ]
    Rate of embolization to an artery not involved in the initially affected territory.

  4. Number of passes with the devices. [ Time Frame: During the procedure ]
    Evaluation of the number of passes with the devices during the procedure.

  5. Procedure time. [ Time Frame: During the procedure ]
    Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention.

  6. Arterial Recanalization (eTICI scale) on first pass. [ Time Frame: During the procedure ]
    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.

  7. Arterial recanalization at the end of the procedures. [ Time Frame: During the procedure ]
    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.

  8. Intracerebral hemorrhage. [ Time Frame: 24 hours ]
    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).

  9. Early neurological improvement. [ Time Frame: 24 hours ]
    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.

  10. National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge. [ Time Frame: 5 days ]
    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.

  11. Modified Rankin Scale (mRS) scale at 90 days. [ Time Frame: 90 days ]
    Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days

  12. Mortality rate. [ Time Frame: 90 days ]
    90-day mortality rate.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930145


Contacts
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Contact: PEDRO VEGA VALDES, MD, PhD 0034985108000 ext 39116 peveval@yahoo.es

Sponsors and Collaborators
Hospital Universitario Central de Asturias
More Information
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Publications:

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Responsible Party: Pedro Vega Valdes, PEDRO VEGA VALDES, Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT05930145    
Other Study ID Numbers: PA 2023.156
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro Vega Valdes, Hospital Universitario Central de Asturias:
Stroke
Double Stentriever
Thrombectomy
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases