The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Patients will undergo mechanical thrombectomy using ATC.
UZ Antwerpen
Edegem, Belgium
NOT_YET_RECRUITINGGhent University Hospital
Ghent, Belgium
Third Pass Reperfusion Assessed by Independent Imaging Core Lab
Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy.
Time frame: Intraoperative
First Pass Reperfusion
Successful achievement of the first pass reperfusion is defined as achieving an eTICI score of 2c or greater, as determined by the independent imaging core lab, with one pass of the study device in the target vessel, and without any rescue therapy.
Time frame: Intraoperative
Final Procedural Reperfusion
Successful achievement of the final procedural reperfusion is defined as achieving a final (end of procedure) eTICI score of 2b50 or greater in the target vessel as determined by the independent imaging core lab.
Time frame: Intraoperative
Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure
Percentage of patients with mRS score of 0-2 at 90 days or no change from baseline if pre-ictal mRS greater than (\>) 2 will be reported.
Time frame: At 90 days post-procedure
Vessel Damage
Number of patients with perforation or dissection in the blood vessel known to be related to or possibly related to the study device will be reported.
Time frame: At 90 days post-procedure
All-Cause Mortality
All mortality regardless of causes at 90 days post-procedure will be reported.
Time frame: At 90 days post-procedure
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Universitair Ziekenhuis Leuven
Leuven, Belgium
NOT_YET_RECRUITINGCHU Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGCHU Nantes
Nantes, France
NOT_YET_RECRUITINGCHU Pitie Salpetriere
Paris, France
NOT_YET_RECRUITINGCentre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, France
NOT_YET_RECRUITINGCHRU de Tours
Tours, France
NOT_YET_RECRUITINGUniversitaetsklinikum Heidelberg
Heidelberg, Germany
NOT_YET_RECRUITINGUniversitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
NOT_YET_RECRUITING...and 5 more locations
Symptomatic Intracranial Hemorrhage (sICH) at 24 hours
sICH is defined as a new intracranial hemorrhage as detected by brain imaging, measured 24 hours after intervention associated with any of the following: greater than or equal to (\>=) 4 points total National Institutes of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; \>= 2 point in one NIHSS category; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention or absence of alternative explanation for deterioration.
Time frame: At 24 hours after intervention