NCT07367100

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Feb 2026

Geographic Reach
5 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

January 16, 2026

Last Update Submit

April 15, 2026

Conditions

Ischemic Stroke

Keywords

Large Vessel OcclusionAcute Ischemic StrokeMechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

  • Third Pass Reperfusion Assessed by Independent Imaging Core Lab

    Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy.

    Intraoperative

Secondary Outcomes (6)

  • First Pass Reperfusion

    Intraoperative

  • Final Procedural Reperfusion

    Intraoperative

  • Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure

    At 90 days post-procedure

  • Vessel Damage

    At 90 days post-procedure

  • All-Cause Mortality

    At 90 days post-procedure

  • +1 more secondary outcomes

Study Arms (1)

Adaptive Tip Catheter (ATC)

EXPERIMENTAL

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.

Procedure: Adaptive Tip Catheter

Interventions

Adaptive Tip CatheterPROCEDURE

Patients will undergo mechanical thrombectomy using ATC.

Adaptive Tip Catheter (ATC)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

UZ Antwerpen

Edegem, 2650, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

CHU Bordeaux

Bordeaux, 33076, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44093, France

NOT YET RECRUITING

CHU Pitie Salpetriere

Paris, 75013, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, 31059, France

NOT YET RECRUITING

CHRU de Tours

Tours, 37000, France

NOT YET RECRUITING

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

NOT YET RECRUITING

Universitaetsmedizin Mainz

Mainz, 55101, Germany

NOT YET RECRUITING

Stadtisches Klinikum Solingen gemeinnutzige GmbH

Solingen, 42653, Germany

NOT YET RECRUITING

Beaumont Hospital

Dublin, 00000, Ireland

NOT YET RECRUITING

VUMC Amsterdam

Amsterdam, 1105 AZ, Netherlands

WITHDRAWN

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christophe Cognard, MD-PhD

    CHU Toulouse - Hôpital, Purpan, Toulouse France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Popovici

CONTACT

+41 76 396 34 66apopovi3@its.jnj.com

Arnaud Nicolas, PhD

CONTACT

+41 79 517 97 36anicolas@its.jnj.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

More information

Locations

BE(3)IE(1)DE(4)FR(5)NL(2)