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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Arterial Occlusive Diseases; Thrombectomy
• Intervention / Treatment: Device: Double stentriever; Device: Single stentriever

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PEDRO VEGA VALDES, MD, PhD; Phone Number: 39116 0034985108000; Email: peveval@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Hospital Universitario Central de Asturias

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Double Stentriever
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Arterial Occlusive Diseases
• Other Study ID Numbers: PA 2023.156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No