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Recruiting Not applicable NCT07367100

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

No applicable phase (e.g. observational)
Conditions: Ischemic Stroke

Sponsor: Neuravi Limited

trial.available_in: БГ
Overview
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
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
Interventions
Adaptive Tip Catheter
PROCEDURE
Locations 15
Belgium (3)
UZ Antwerpen
Edegem
Ghent University Hospital
Ghent
Universitair Ziekenhuis Leuven
Leuven
France (5)
CHU Bordeaux
Bordeaux
NOT_YET_RECRUITING
CHU Nantes
Nantes
NOT_YET_RECRUITING
CHU Pitie Salpetriere
Paris
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse
NOT_YET_RECRUITING
CHRU de Tours
Tours
NOT_YET_RECRUITING
Germany (4)
Universitaetsklinikum Heidelberg
Heidelberg
NOT_YET_RECRUITING
Universitatsklinikum Schleswig Holstein Kiel
Kiel
NOT_YET_RECRUITING
Universitaetsmedizin Mainz
Mainz
NOT_YET_RECRUITING
Stadtisches Klinikum Solingen gemeinnutzige GmbH
Solingen
NOT_YET_RECRUITING
Ireland (1)
Beaumont Hospital
Dublin
NOT_YET_RECRUITING
Netherlands (2)
VUMC Amsterdam
Amsterdam
WITHDRAWN
Maastricht University Medical Centre
Maastricht
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
02.02.2026
Completion date
31.07.2027
Registry ID
NCT07367100
Source
clinicaltrials.gov
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