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

Fundación EPIC

Status: Enrolling

Conditions: Thrombectomy; Stroke; Arterial Occlusive Diseases

Treatments: Device: Double stentriever; Device: Single stentriever

Study type: Interventional

Funder types: Other

Identifiers

NCT05930145

EPIC42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Double stentriever technique

Experimental group

Description:

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)

Treatment:

Device: Double stentriever

Single stentriever technique

Active Comparator group

Description:

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

Treatment:

Device: Single stentriever