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

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Adaptive Tip Catheter

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana Popovici; Phone Number: +41 76 396 34 66; Email: apopovi3@its.jnj.com
• Study Contact Backup: Name: Arnaud Nicolas, PhD; Phone Number: +41 79 517 97 36; Email: anicolas@its.jnj.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • CHU Bordeaux
  • Nantes, France, 44093
    • Not yet recruiting
    • Chu Nantes
  • Paris, France, 75013
    • Not yet recruiting
    • CHU Pitie Salpetriere
  • Toulouse, France, 31059
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Tours, France, 37000
    • Not yet recruiting
    • CHRU de Tours
• Germany
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • Universitaetsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Not yet recruiting
    • Universitatsklinikum Schleswig Holstein Kiel
  • Mainz, Germany, 55101
    • Not yet recruiting
    • Universitaetsmedizin Mainz
  • Solingen, Germany, 42653
    • Not yet recruiting
    • Stadtisches Klinikum Solingen gemeinnutzige GmbH
• Ireland
  • Dublin, Ireland, 00000
    • Not yet recruiting
    • Beaumont Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Withdrawn
    • VUMC Amsterdam
  • Maastricht, Netherlands, 6229 HX
    • Not yet recruiting
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients will undergo mechanical thrombectomy using ATC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At 90 days post-procedure
All-Cause Mortality	All mortality regardless of causes at 90 days post-procedure will be reported.	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.	At 24 hours after intervention

Collaborators and Investigators

• Sponsor: Neuravi Limited
• Investigators: Principal Investigator: Christophe Cognard, MD-PhD, CHU Toulouse - Hôpital, Purpan, Toulouse France

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Large Vessel Occlusion; Acute Ischemic Stroke; Mechanical Thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CNV202304 (Neuravi Limited)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No