About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
Disqualifiers
Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
Life expectancy less than (<) 90 days prior to stroke onset
Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
Trial design
Single group
Treatments tested in this trial
Adaptive Tip Catheter
Procedure/SurgeryPatients will undergo mechanical thrombectomy using ATC.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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