Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients

March 22, 2026 updated by: Ceretrieve Ltd.

Evaluation of the Safey & Performance of the Ceretrieve Device Designed for Thrombus Removal in Intracranial Arteries Using an Aspiration Technique in Patients Suffering an Acute Ischemic Stroke (AIS)

The main objective of this clinical trial is to evaluate of the safety & efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure. This means to assess that the use with the Ceretrieve neuro-thrombectomy device that is designed to treat acute ischemic stroke patients raises no safety concerns and that it is found to be effective when it is used according to its intended purpose, which is revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (involving the internal carotid artery, middle cerebral artery- M1 and M2 segments, basilar, and vertebral arteries).

The study researchers will compare the efficacy and safety results of this study to data derived from the literature of FDA approved neuro-thrombectomy devices. The study hypothesis is that The Ceretrieve device would achieve successful reperfusion performance shall be similar to the safety & performance derived from the literature.

The primary outcomes that will be measures are:

Performance:

Successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Ceretrieve system without any rescue.

Safety:

Symptomatic intra-cranial hemorrhage within 24 (18-36) hours of the study procedure.

Patients who will participate in this study will be followed for a time period of 3 months. After discharge from the medical center, they will be asked to arrive to a one visit at the clinic for safety data collection and evaluation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a prospective, multi-center, open-label, single-arm study.

Patient will be required to undergo screening evaluation to confirm he/she meet the eligibility study criteria and are suitable to be a study participant.

The study patient population is comprised of adult subjects 18 years old and above, suffering from acute ischemic stroke, with a new moderate-to-severe neurologic deficits, angiographically confirmed occlusion in the intracranial internal carotid, middle cerebral (M1 or M2 segment), basilar, or vertebral artery, and can undergo endovascular therapy (at least one Ceretrieve deployment in the target artery), within 24 hours of symptoms on set.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years of age
  2. Clinical signs consistent with acute ischemic stroke
  3. Subject is able to be treated within 24 hours of stroke symptom onset.
  4. Pre-stroke modified Rankin Score of 0 or 1
  5. NIHSS > 6 at the time of screening
  6. If intravenous thrombolysis (IVT) is indicated, initiation of IVT should be administered as soon as possible and no later than 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IVT dose for the estimated weight.
  7. Intracranial occlusion defined as Modified Thrombolysis in Cerebral Infarction (mTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:

1. Intracranial internal carotid artery 2. M1 and/or M2 segment of the MCA 3. Vertebral artery 4. Basilar artery Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.

8. A valid completed informed consent in accordance with the local ethics committee regulations.

Exclusion Criteria:

  1. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
  2. Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
  3. Known serious sensitivity to radiographic contrast agents
  4. Known sensitivity to nickel, titanium metals, or their alloys
  5. Subjects already enrolled in other investigational studies that would interfere with study endpoints
  6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
  7. Life expectancy of less than 90 days
  8. Clinical presentation suggests a subarachnoid hemorrhage, even if the initial CT or MRI scan is normal.
  9. Suspicion of aortic dissection
  10. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
  11. Known to currently use or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
  12. Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
  13. Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
  14. Angiographic evidence of carotid dissection

  15. Imaging exclusion criteria:

    • CT or MRI evidence of hemorrhage on presentation
    • CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
    • CT or MRI evidence of cerebral vasculitis
    • CT or MRI-DWI showing ASPECTS 0-5 (or pc-ASPECTS 0-6 in the posterior circulation). Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 70cc.
    • CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
    • Any imaging evidence that suggests, in the opinion of the investigator, that the subject is not appropriate for mechanical thrombectomy intervention while utilizing an aspiration approach (e.g. inability to navigate to the target lesion, moderate/large infarct with poor collateral circulation, etc.).
  16. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ceretrieve treatment arm - patient will be treated with the Ceretrieve device - aspiration approach
This is the only study arm. All patients found to be eligible will be treated with the Ceretrieve device.
Device: Aspiration 0
Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Reperfusion (mTICI 2b-3) Within Three Passes Without Rescue Therapy
Time Frame: intra-procedural
Successful reperfusion defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2b-3 achieved within three passes of the Ceretrieve system without use of rescue therapy.
intra-procedural
Number of Participants With Symptomatic Intracranial Hemorrhage Within 24 (18-36) Hours Post-Procedure
Time Frame: 24 (18-36) hours post procedure
Symptomatic intracranial hemorrhage assessed within 24 (18-36) hours following the procedure.
24 (18-36) hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceretrieve Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2024

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA 304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data in the study will undergo pseudo-anonymization process and there will be no identifiable details in the data collected on all study patients.

In this study, all endpoints are aimed at assessing/analyzing events' rates to be compared against the applicable historical data, and not the review of individual cases data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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