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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients.
Heidelberg University Hospital
Heidelberg, Germany
RECRUITINGEfficacy
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.
Time frame: intra-procedural
Safety
Symptomatic Intra-cranial hemorrhage within 24 (18-36) hours post procedure
Time frame: 24 (18-36) hours post procedure
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