A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
Belgium
UZ Antwerpen
NOT_YET_RECRUITING
Edegem
Ghent University Hospital
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
NOT_YET_RECRUITING
Leuven
France
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Nantes
NOT_YET_RECRUITING
Nantes
CHU Pitie Salpetriere
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
NOT_YET_RECRUITING
Toulouse
CHRU de Tours
NOT_YET_RECRUITING
Tours
Germany
Universitaetsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Universitatsklinikum Schleswig Holstein Kiel
NOT_YET_RECRUITING
Kiel
Universitaetsmedizin Mainz
NOT_YET_RECRUITING
Mainz
Stadtisches Klinikum Solingen gemeinnutzige GmbH
NOT_YET_RECRUITING
Solingen
Ireland
Beaumont Hospital
NOT_YET_RECRUITING
Dublin
Netherlands
VUMC Amsterdam
NOT_YET_RECRUITING
Amsterdam
Maastricht University Medical Centre
NOT_YET_RECRUITING
Maastricht
Contact Information
Primary
Adriana Popovici
apopovi3@its.jnj.com
+41 76 396 34 66
Backup
Arnaud Nicolas, PhD
anicolas@its.jnj.com
+41 79 517 97 36
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 74
Treatments
Experimental: Adaptive Tip Catheter (ATC)
The ATC will be used alone (direct aspiration) as the first attempted device/technique for mechanical thrombectomy in the anterior circulation in patients during the first three passes or until final reperfusion, if less than three passes are needed. Patients will be followed over 90 days post procedure.
Related Therapeutic Areas
Sponsors
Leads: Neuravi Limited

This content was sourced from clinicaltrials.gov

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