Condition: Acute Ischemic Stroke · Sponsor: Ceretrieve Ltd.
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 o…
This description comes directly from the study's public registry record.
Hilla Hilla Ben-Ezra, Ms. · +972-52-6511131 · hilla@ceretrieve.com
Maysa Mustafa, Ms. · +972-50-2158126 · Maysa@ceretrieve.com
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| Heidelberg University Hospital | Heidelberg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06733246