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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Stroke, Thrombectomy, Arterial Occlusive Diseases

Intervention / Treatment
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* Device: Double stentriever
* Device: Single stentriever


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double stentriever technique<br>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<br>* Double stentriever technique<br>|
| Active Comparator: Single stentriever technique<br>Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm). | Device: Single stentriever<br>* Single stentriever technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 90 days | 
| 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention success. | Rate of the ability to position both STs in the indicated location. | During the procedure | 
| Complications related to the intervention. | Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm. | During the procedure | 
| Embolism in new territories. | Rate of embolization to an artery not involved in the initially affected territory. | During the procedure | 
| Number of passes with the devices. | Evaluation of the number of passes with the devices during the procedure. | During the procedure | 
| Procedure time. | Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention. | During the procedure | 
| 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. | During the procedure | 
| 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. | During the procedure | 
| 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). | 24 hours | 
| 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. | 24 hours | 
| 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. | 5 days | 
| 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 | 90 days | 
| Mortality rate. | 90-day mortality rate. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Double Stentriever, Thrombectomy