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
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitatsklinikum Schleswig Holstein Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| Universitaetsmedizin Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Stadtisches Klinikum Solingen gemeinnutzige GmbH Coordinator of this site? Confirm its status | Solingen | Germany | Recruiting |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse - Hopital Purpan Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.