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

NCT05930145 | Recruiting

• 1 other identifier: EPIC42
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 4

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.

Conditions

Stroke; Thrombectomy; Arterial Occlusive Diseases

Keywords

Stroke; Double Stentriever; Thrombectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Intervention success.

  During the procedure

• Complications related to the intervention.

  During the procedure

• Embolism in new territories.

  During the procedure

• Number of passes with the devices.

  During the procedure

• Procedure time.

  During the procedure

Study Arms (2)

Double stentriever technique

EXPERIMENTAL

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

Single stentriever technique

ACTIVE COMPARATOR

Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).

Device: Single stentriever

Interventions

Double stentriever DEVICE

Double stentriever technique

Double stentriever technique

Single stentriever DEVICE

Single stentriever technique

Single stentriever technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (4)

Alfried Krupp Hospital Ruettenscheid

Essen, Germany

RECRUITING

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

PEDRO VEGA VALDES, MD, PhD

CONTACT

0034985108000; peveval@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient \& Outcomes adjudicator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 5, 2023
• Study Start: March 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (3)