A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With A… (NCT07367100) | Clinical Trial Compass
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A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Belgium, France74 participantsStarted 2026-02-02
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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/ M…
What they're measuring
1
Third Pass Reperfusion Assessed by Independent Imaging Core Lab