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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2026-10-01

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.

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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.

Conditions

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Stroke Thrombectomy Arterial Occlusive Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Patient \& Outcomes adjudicator

Study Groups

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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)

Group Type EXPERIMENTAL

Double stentriever

Intervention Type DEVICE

Double stentriever technique

Single stentriever technique

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

Group Type ACTIVE_COMPARATOR

Single stentriever

Intervention Type DEVICE

Single stentriever technique

Interventions

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Double stentriever

Double stentriever technique

Intervention Type DEVICE

Single stentriever

Single stentriever technique

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No