Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
NCT: NCT06733246 · RECRUITING
Brief 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.
Frequently Asked Questions
What is Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients?
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients is a clinical trial registered under NCT06733246. Current status: RECRUITING.
What is the status of NCT06733246?
The current status of NCT06733246 (Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients) is: RECRUITING.
When did Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients start?
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients started on 2024-11-12.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.