Ischemic StrokePHASTNCT07367100
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
A study testing Adaptive Tip Catheter in people with Ischemic Stroke, run by Neuravi Limited at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Adaptive Tip Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 2 Feb 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Germany4 sites, 4 recruiting
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
- Recruiting
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105
- Recruiting
Universitaetsmedizin Mainz
Mainz, 55101
- Recruiting
Stadtisches Klinikum Solingen gemeinnutzige GmbH
Solingen, 42653
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen
Edegem, 2650
- Recruiting
Ghent University Hospital
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
France3 sites, 3 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33076
- Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, 31059
- Recruiting
CHRU de Tours
Tours, 37000
About this study
Official title: A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
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.
- Conditions
- Ischemic Stroke
- Being tested
- Adaptive Tip Catheter
- Keywords
- Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Tip CatheterProcedure or surgery
Patients will undergo mechanical thrombectomy using ATC.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Adaptive Tip Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Secondary outcomes (6)
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.
Measured: Intraoperative
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.
Measured: Intraoperative
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.
Measured: At 90 days post-procedure
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.
Measured: At 90 days post-procedure
All-Cause Mortality
All mortality regardless of causes at 90 days post-procedure will be reported.
Measured: At 90 days post-procedure
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.
Measured: At 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuravi Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Cognard, MD-PhD, Principal investigator, CHU Toulouse - Hôpital, Purpan, Toulouse France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367100
- Sponsor's protocol ID
- CNV202304
- Acronym
- PHAST
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT07367100
- Acronym / sponsor ID
- PHAST / CNV202304
- Conditions
- Ischemic Stroke
- Keywords
- Large Vessel Occlusion, Acute Ischemic Stroke, Mechanical Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Neuravi LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Tip Catheter (ATC) | Experimental | Procedure: Adaptive Tip CatheterThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Tip CatheterPatients will undergo mechanical thrombectomy using ATC. | Procedure or surgery | Adaptive Tip Catheter (ATC) |
Primary outcome
Third Pass Reperfusion Assessed by Independent Imaging Core Lab
Time frame: Intraoperative
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.
6 secondary outcomes
First Pass Reperfusion
Time frame: Intraoperative
Final Procedural Reperfusion
Time frame: Intraoperative
Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure
Time frame: At 90 days post-procedure
Vessel Damage
Time frame: At 90 days post-procedure
All-Cause Mortality
Time frame: At 90 days post-procedure
Symptomatic Intracranial Hemorrhage (sICH) at 24 hours
Time frame: At 24 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe Cognard, MD-PhD principal investigator
CHU Toulouse - Hôpital, Purpan, Toulouse France
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Tip Catheter in people with Ischemic Stroke, run by Neuravi Limited at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana Popovici (+41 76 396 34 66, apopovi3@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Third Pass Reperfusion Assessed by Independent Imaging Core Lab (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.