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

Sponsor

Hospital Universitario Central de Asturias (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05930145

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Thrombectomy Arterial Occlusive Diseases	Device: Double stentriever Device: Single stentriever	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Patient & Outcomes adjudicator

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Device: Double stentriever Double stentriever technique
Active Comparator: Single stentriever technique Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm).	Device: Single stentriever Single stentriever technique

Arm

Intervention/Treatment

Experimental: 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)

Device: Double stentriever

Double stentriever technique

Active Comparator: Single stentriever technique

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

Device: Single stentriever

Single stentriever technique

Outcome Measures

Primary Outcome Measures

EFFECTIVENESS OBJECTIVE [90 days]
First pass effect understood as complete recanalization on the 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 (Thrombolysis in Cerebral Infarction) greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
SAFETY OBJECTIVE [90 days]
no statistically significant differences in the percentage of 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.

Secondary Outcome Measures

Intervention success. [90 days]
ability to position both STs in the indicated location.
Complications during the intervention. [90 days]
arterial perforation, angiographic extravasation of contrast, arterial dissection, arterial vasospasm.
Embolism to an artery not involved in the initially affected territory. [90 days]
Embolism to an artery not involved in the initially affected territory.
Number of passes with the devices. [90 days]
Number of passes with the devices.
Time from symptom onset to arterial puncture, time from symptom onset to arterial recanalization, or if not achieved, until the end of the intervention. [90 days]
Time from symptom onset to arterial puncture, time from symptom onset to arterial recanalization, or if not achieved, until the end of the intervention.
Recanalization rates (eTICI scale): eTICI 3 on the first pass, eTICI 2c/3 on the first pass, eTICI e2b/3 on the first pass, eTICI 3 final, eTICI e2c/3 final, eTICI e2b/3 final. [90 days]
Recanalization rates (eTICI scale): eTICI 3 on the first pass, eTICI 2c/3 on the first pass, eTICI e2b/3 on the first pass, eTICI 3 final, eTICI e2c/3 final, eTICI e2b/3 final.
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). [90 days]
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).
Early neurological improvement defined as a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours. [90 days]
Early neurological improvement defined as a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours.
Clinical evolution according to the NIHSS scale at 24 hours, on day 5, or at discharge. [90 days]
Clinical evolution according to the NIHSS scale at 24 hours, on day 5, or at discharge.
Clinical evolution according to the mRS scale [90 days]
Clinical evolution according to the mRS scale
Rate of satisfactory reperfusion at the end of procedure, defined as the achievement of a modified Thrombolysis in Cerebral Infarction - mTICI ( Thrombolysis in Cerebral Infarction)≥2b in the target vessel in 3 passes and at the end of the procedure. [4 months]
Rate of satisfactory reperfusion at the end of procedure, defined as the achievement of a modified Thrombolysis in Cerebral Infarction - mTICI ≥2b in the target vessel in 3 passes and at the end of the procedure.
Procedure time, defined as the time from puncture to obtaining mTICI ≥2b or, if not obtained, to final angiography. [4 months]
Procedure time, defined as the time from puncture to obtaining mTICI ≥2b or, if not obtained, to final angiography.
Percentage of functionally independent patients (mRS <=2) at day 5 or discharge [90 days]
Percentage of functionally independent patients (mRS <=2) at day 5 or discharge
Mortality rate [90 days]
Mortality rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)