First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: iNedit, iNdeep and iNtercept in patients with acute ischemic stroke.
This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research. The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well). Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal.
Study Type
OBSERVATIONAL
Enrollment
175
Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept
Hospital AZ Groeninge
Kortrijk, Belgium
Hospital Klinikum Ludwigsburg
Ludwigsburg, Germany
Performance Success
To assess the ability of the system to successfully perform a neurothrombectomy using the three devices to be evaluated and with ≤3 insertions (passes) of the stent retriever.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
MAE
All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.
Time frame: 24 hours (-8/+12 hours)
Mortality
All-cause mortality
Time frame: 90 days
Clinical progress
Good functional clinical progress (modified Rankin scale 0-2)
Time frame: 90 days
Proportion of patients with rapid neurological improvement
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS ≤4)
Time frame: 24 hours after treatment
Reduction of NIHSS scale
Proportion of patients with a reduction of ≥8 points on the NIHSS scale or NIHSS 0-1
Time frame: At 72 hours or at the time of discharge, whichever occurs first.
Procedure duration
Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
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Hospital LMU Klinikum
Munich, Germany
Hospital Klinikum Nürnberg
Nuremberg, Germany
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital de Cruces
Barakaldo, Spain
Hospital de la Vall d'Hebrón
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
...and 8 more locations
Number of passes with the device until recanalization.
Number of passes with the device until recanalization.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Percentage of effective recanalization in a first pass.
Percentage of effective recanalization in a first pass.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Rate of cases that reached the occlusion and allowed the performance of the trombectomy.
Rate of cases where the microcatheter and the distal access balloon catheter reached the occlusion in the main vessel to allow navigation and deployment of the stent retriever to carry out the neurothrombectomy.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Assessment of intracranial haemorrhage (ICH)
Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT).
Time frame: 24 (-8/+12) hours
Neurological deterioration
Classification of neurological deterioration of ≥4 points on the NIHSS scale
Time frame: 24 (-8/+12) hours.
Embolization rate
Embolization rate in a previously non-involved territory on cerebral angiography.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Mortality rate
Mortality rate related to the procedure
Time frame: 3 days (+/-24) hours
Procedure complication rate
Procedure complication rate: arterial perforation, arterial dissection and vasospasm in the target vessel and embolization in a previously non-involved vascular territory.
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Rate of infarction in a previously non-involved vascular territory
Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT).
Time frame: 24 hours.