Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Double stentriever
DeviceDouble stentriever technique
Single stentriever
DeviceSingle stentriever technique
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Double stentriever techniqueExperimental treatment 1 intervention
Group B: Single stentriever techniqueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
90 days2
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.
Time frame
24 hoursSecondary outcomes
1
Intervention success.
Rate of the ability to position both STs in the indicated location.
Time frame
During the procedure2
Complications related to the intervention.
Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.
Time frame
During the procedure3
Embolism in new territories.
Rate of embolization to an artery not involved in the initially affected territory.
Time frame
During the procedure4
Number of passes with the devices.
Evaluation of the number of passes with the devices during the procedure.
Time frame
During the procedureSponsors and contacts
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Source ClinicalTrials.gov