Adaptive Tip Catheter for first-line aspiration thrombectomy in 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

This trial will try the Adaptive Tip Catheter as the first treatment to suction out clots in adults (18–90) with anterior large-vessel ischemic stroke who can be treated within 24 hours.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Neuravi Limited (Industry-sponsored)
• Locations: 15 sites (Edegem and 14 other locations)
• Trial ID: NCT07367100 on ClinicalTrials.gov

What this trial studies

This multicenter study uses the Adaptive Tip Catheter as a first-line direct aspiration device to remove clots in patients with anterior-circulation large-vessel occlusion. Eligible adults must have an NIHSS score of 6 or more, ASPECTS of 3 or higher, and be able to start endovascular access within 24 hours of last known well. The trial will collect safety and effectiveness data following use of the catheter during mechanical thrombectomy procedures. Sites include major university hospitals in Belgium and the sponsor is Neuravi Limited.

Who should consider this trial

Good fit: Adults aged 18–90 with anterior-circulation large-vessel occlusion, NIHSS ≥6, ASPECTS ≥3, and who can undergo endovascular thrombectomy within 24 hours are the intended candidates.

Not a fit: Patients who are pregnant, have life expectancy under 90 days, known bleeding/diathesis disorders, posterior-circulation strokes, very mild strokes (NIHSS <6), very low ASPECTS (<3), or who cannot be treated at a participating center in time are unlikely to benefit.

Why it matters

Potential benefit: If successful, this catheter could remove clots faster or with fewer complications, improving patients' chances of functional recovery.

How similar studies have performed: Direct aspiration thrombectomy techniques have demonstrated good results in prior trials, but this specific adaptive-tip catheter is a newer device with limited device-specific outcome data.

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

Where this trial is running

Edegem and 14 other locations

• UZ Antwerpen — Edegem, Belgium (Recruiting)
• Ghent University Hospital — Ghent, Belgium (Recruiting)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (Recruiting)
• CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
• CHU Nantes — Nantes, France (Not_yet_recruiting)
• CHU Pitie Salpetriere — Paris, France (Not_yet_recruiting)
• Centre Hospitalier Universitaire de Toulouse - Hopital Purpan — Toulouse, France (Not_yet_recruiting)
• CHRU de Tours — Tours, France (Not_yet_recruiting)
• Universitaetsklinikum Heidelberg — Heidelberg, Germany (Not_yet_recruiting)
• Universitatsklinikum Schleswig Holstein Kiel — Kiel, Germany (Not_yet_recruiting)
• Universitaetsmedizin Mainz — Mainz, Germany (Not_yet_recruiting)
• Stadtisches Klinikum Solingen gemeinnutzige GmbH — Solingen, Germany (Not_yet_recruiting)
• Beaumont Hospital — Dublin, Ireland (Not_yet_recruiting)
• VUMC Amsterdam — Amsterdam, Netherlands (Withdrawn)
• Maastricht University Medical Centre — Maastricht, Netherlands (Not_yet_recruiting)

Study contacts

• Principal investigator: Christophe Cognard, MD-PhD — CHU Toulouse - Hôpital, Purpan, Toulouse France
• Study coordinator: Adriana Popovici

Conditions Ischemic Stroke; Large Vessel Occlusion; Acute Ischemic Stroke; Mechanical Thrombectomy