NCT07367100 A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
| NCT ID | NCT07367100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuravi Limited |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2026-02-02 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Christophe Cognard, MD-PhD
PRINCIPAL INVESTIGATOR
CHU Toulouse - Hôpital, Purpan, Toulouse France
Frequently Asked Questions
Who can join the NCT07367100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07367100 currently recruiting?
Yes, NCT07367100 is actively recruiting participants. Contact the research team at apopovi3@its.jnj.com for enrollment information.
Where is the NCT07367100 trial being conducted?
This trial is being conducted at Edegem, Belgium, Ghent, Belgium, Leuven, Belgium, Bordeaux, France and 9 additional locations.
Who is sponsoring the NCT07367100 clinical trial?
NCT07367100 is sponsored by Neuravi Limited. The principal investigator is Christophe Cognard, MD-PhD at CHU Toulouse - Hôpital, Purpan, Toulouse France. The trial plans to enroll 74 participants.
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