Adaptive Tip Catheter: Patients will undergo mechanical thrombectomy using ATC.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion criteria:
* 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
* Baseline Alberta Stroke Program Early CT Score (ASPECTS) \>= 3
* A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained
Exclusion criteria:
* 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)
* Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
* Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
* Baseline CT or MRI showing mass effect
* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
* Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
* Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
* Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
* Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
* Baseline expanded thrombolysis in cerebral infarction (eTICI) \> 1
Primary outcome measure(s)
Third Pass Reperfusion Assessed by Independent Imaging Core Lab — Intraoperative 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.
Trial sites (10)
Facility
City
Region
Status
UZ Antwerpen
Edegem
Belgium
Recruiting
Ghent University Hospital
Ghent
Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven
Belgium
Recruiting
CHU Bordeaux
Bordeaux
France
Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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