ClinicalTrials.gg
RecruitingNCT07367100PHASTUpdated Nov 5, 2026

A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

An interventional study of Adaptive Tip Catheter in Ischemic Stroke, sponsored by Neuravi Limited. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Neuravi Limited (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Updated Nov 5, 2026First site in Ireland3 sites addedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke

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Keywords

  • Large Vessel Occlusion
  • Acute Ischemic Stroke
  • Mechanical Thrombectomy
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 74 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Neuravi Limited is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

First submitted after Neuravi Limited became part of Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained

Exclusion criteria

Exclusion criteria:

  • Known pregnancy, as evidenced by positive pregnancy test for women of or breast feeding
  • less than (\<) 90 days prior to stroke onset
  • Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known (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 (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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (estimated)

Study arms

  • 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.

    Procedure: Adaptive Tip Catheter

Interventions

  • ProcedureAdaptive Tip Catheter

    Patients will undergo mechanical thrombectomy using ATC.

06

What researchers measure

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.

    Time frame: Intraoperative

Secondary outcomes

  1. First Pass Reperfusion

    Successful achievement of the first pass reperfusion is defined as achieving an eTICI score of 2c or greater, as determined by the independent imaging core lab, with one pass of the study device in the target vessel, and without any rescue therapy.

    Time frame: Intraoperative

  2. Final Procedural Reperfusion

    Successful achievement of the final procedural reperfusion is defined as achieving a final (end of procedure) eTICI score of 2b50 or greater in the target vessel as determined by the independent imaging core lab.

    Time frame: Intraoperative

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

    Percentage of patients with mRS score of 0-2 at 90 days or no change from baseline if pre-ictal mRS greater than (\>) 2 will be reported.

    Time frame: At 90 days post-procedure

  4. Vessel Damage

    Number of patients with perforation or dissection in the blood vessel known to be related to or possibly related to the study device will be reported.

    Time frame: At 90 days post-procedure

  5. All-Cause Mortality

    All mortality regardless of causes at 90 days post-procedure will be reported.

    Time frame: At 90 days post-procedure

  6. Symptomatic Intracranial Hemorrhage (sICH) at 24 hours

    sICH is defined as a new intracranial hemorrhage as detected by brain imaging, measured 24 hours after intervention associated with any of the following: greater than or equal to (\>=) 4 points total National Institutes of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; \>= 2 point in one NIHSS category; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention or absence of alternative explanation for deterioration.

    Time frame: At 24 hours after intervention

07

Study locations

13 of 13 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Apr 2027, 14 months after the start.

Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 14 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2026
First posted
Jan 26, 2026
StartActual
Feb 2, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Jul 31, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added — first site in Ireland
Show 3 added (2 France, 1 Ireland)
  • CHU Nantes · Nantes, France
  • CHU Pitie Salpetriere · Paris, France
  • Beaumont Hospital · Dublin, Ireland
Nov 5, 2026
Show all 2 updates
  1. Nov 5, 2026
    3 sites added — first site in Ireland
    Show 3 added (2 France, 1 Ireland)
    • CHU Nantes · Nantes, France
    • CHU Pitie Salpetriere · Paris, France
    • Beaumont Hospital · Dublin, Ireland
    + 1 other change: verification date
  2. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07367100
Lead sponsor
Neuravi Limited
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Feb 2, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Adriana Popovici
Contact
apopovi3@its.jnj.com
+41 76 396 34 66
Arnaud Nicolas, PhD
Contact
anicolas@its.jnj.com
+41 79 517 97 36
Christophe Cognard, MD-PhD
principal investigator · CHU Toulouse - Hôpital, Purpan, Toulouse France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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