A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
- Ischemic Stroke
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Neuravi Limited
- Enrolment target
- 74
- Started
- 2 February 2026
- Main results due
- 30 April 2027
- Study sites
- 10
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 90 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(10)
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
Toulouse, France
Recruiting
CHRU de Tours
Tours, France
Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Recruiting
Universitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
Recruiting
Universitaetsmedizin Mainz
Mainz, Germany
Recruiting
Stadtisches Klinikum Solingen gemeinnutzige GmbH
Solingen, Germany
Recruiting
Showing 10 of 10 sites. 10 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07367100. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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