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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05930145
• Other study ID #: PA 2023.156
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: Hospital Universitario Central de Asturias
• Contact: PEDRO VEGA VALDES, MD, PhD
• Phone: 0034985108000
• Email: peveval[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Ischemic Stroke
• Stroke
• Thrombectomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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