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.

Overview

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.

Interventions

• Device Double stentriever
  Double stentriever technique
• Device Single stentriever
  Single stentriever technique

Primary outcome measures

• EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass [Time frame: 90 days]
• SAFETY OBJECTIVE: Intracerebral hemorrhage. [Time frame: 24 hours]

Secondary outcome measures (12)

• Intervention success. [Time frame: During the procedure]
• Complications related to the intervention. [Time frame: During the procedure]
• Embolism in new territories. [Time frame: During the procedure]
• Number of passes with the devices. [Time frame: During the procedure]
• Procedure time. [Time frame: During the procedure]
• Arterial Recanalization (eTICI scale) on first pass. [Time frame: During the procedure]
• Arterial recanalization at the end of the procedures. [Time frame: During the procedure]
• Intracerebral hemorrhage. [Time frame: 24 hours]
• Early neurological improvement. [Time frame: 24 hours]
• National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge. [Time frame: 5 days]
• Modified Rankin Scale (mRS) scale at 90 days. [Time frame: 90 days]
• Mortality rate. [Time frame: 90 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 3 centers

• Hospital Universitario de Cruces — Barakaldo
• Hospital Universitario Central de Asturias — Oviedo
• Hospital Clínico Universitario de Valladolid — Valladolid

Germany · 1 center

• Alfried Krupp Hospital Ruettenscheid — Essen

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. PMID 35416489
• 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 Dec;15(12):1224-1228. doi: 10.1136/jnis-2022-019887. Epub 2023 Jan 10. PMID 36627194
• 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. PMID 28366064
• 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. PMID 34233944
• 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. PMID 32973671

Identifiers

NCT: NCT05930145 · EPIC42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗