A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNeuravi Limited

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

Qualifiers

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

Treatments tested in this trial

  • Adaptive Tip Catheter

Treatment groups

74 Participants
are divided into 1 treatment group

Sponsors and collaborators