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NCT07367100
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Conditions: Ischemic Stroke
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 74
Sponsor: Neuravi Limited
Location: UZ Antwerpen Edegem
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 Criteria
Inclusion criteria:
* Age greater than or equal to (\>=) 18 years, less than or equal to (\= 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 (\) 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
Source: ClinicalTrials.gov (NCT07367100). StuddyBuddy aggregates publicly available trial information.