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NCT07367100From ClinicalTrials.govRecruiting

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