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NCT07367100Recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
74 (estimated)
First submitted
16 Jan 2026
Start date
2 Feb 2026
Primary completion date
30 Apr 2027
Lead sponsor
Neuravi Limited
Diseases
Stroke
NCT number
NCT07367100

What you commit to

  • Study type: Interventional
  • Planned participants: 74
  • From 2 Feb 2026 to the primary completion date, 30 Apr 2027
  • 10 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Life expectancy less than (\<) 90 days prior to stroke onset
  • 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

Other illness

  • 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)
  • Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
  • Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)

Lab values

  • Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (\>) 3.0

Other

  • Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
  • Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
  • Baseline CT or MRI showing mass effect
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZ Antwerpen
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EdegemBelgiumRecruiting
Ghent university hospital
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GhentBelgiumRecruiting
Universitair Ziekenhuis Leuven
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LeuvenBelgiumRecruiting
Universitaetsklinikum Heidelberg
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HeidelbergGermanyRecruiting
Universitatsklinikum Schleswig Holstein Kiel
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KielGermanyRecruiting
Universitaetsmedizin Mainz
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MainzGermanyRecruiting
Stadtisches Klinikum Solingen gemeinnutzige GmbH
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SolingenGermanyRecruiting
CHU Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
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ToulouseFranceRecruiting
CHRU de Tours
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ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.