Tests a catheter device for removing clots in acute ischemic stroke
Tests a clot-removal catheter in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Key facts
- Where
- Bordeaux, Nantes, Paris, Toulouse, and Tours, FranceSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07367100, who can take part
Where in France
- CHU BordeauxBordeaux, FranceTaking people
- CHU NantesNantes, FranceTaking people
- CHU Pitie SalpetriereParis, FranceTaking people
- Centre Hospitalier Universitaire de Toulouse - Hopital PurpanToulouse, FranceTaking people
- CHRU de ToursTours, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuravi Limited
- Trial code
- NCT07367100
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
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.
Inclusion: 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: 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; 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); Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0; 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.