Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06733246

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

Led by Ceretrieve Ltd. · Updated on 2026-03-25

132

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical signs consistent with acute ischemic stroke
  • Able to be treated within 24 hours of stroke symptom onset
  • Pre-stroke modified Rankin Score of 0 or 1
  • NIH Stroke Scale score greater than 6 at screening
  • If intravenous thrombolysis is indicated, treatment started within 4.5 hours of stroke onset with correct dosing
  • Angiographically confirmed blockage (mTICI 0-1 flow) in intracranial internal carotid, M1 or M2 segment of middle cerebral artery, vertebral artery, or basilar artery accessible to the device
  • Informed consent completed according to local ethics regulations
Not Eligible

You will not qualify if you...

  • Female who is pregnant, lactating, or has a positive pregnancy test at admission
  • Rapid neurological improvement before enrollment suggesting stroke symptoms resolved
  • Known serious allergy to radiographic contrast agents
  • Known allergy to nickel, titanium, or their alloys
  • Participation in other investigational studies interfering with this study
  • Known bleeding disorders or coagulation factor deficiencies
  • Life expectancy less than 90 days
  • Clinical signs suggesting subarachnoid hemorrhage even if initial scans are normal
  • Suspected aortic dissection
  • Comorbid conditions that affect neurological evaluations, survival, or follow-up
  • Regular or daily consumption of more than four alcoholic drinks per day
  • Arterial conditions preventing safe device use or recovery
  • Requirement for balloon angioplasty or carotid stenting at the time of procedure
  • Angiographic evidence of carotid dissection
  • Imaging showing hemorrhage, tumors (except small meningioma), vasculitis, low ASPECTS scores, large core infarcts, carotid dissection, or conditions unsuitable for mechanical thrombectomy
  • Occlusions in multiple vascular territories or evidence of multiple strokes

AI-Screening

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Trial Site Locations

Total: 1 location

1

Heidelberg University Hospital

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

H

Hilla Hilla Ben-Ezra, Ms.

CONTACT

M

Maysa Mustafa, Ms.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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