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

NCT06733246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-03-25

No results posted yet for this study

Summary

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

  • Acute Ischemic Stroke

Interventions

DEVICE

Aspiration 0

Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients.

Sponsors & Collaborators

  • Ceretrieve Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2027-05-30
Completion
2027-08-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733246 on ClinicalTrials.gov