Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients (NCT06733246) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
Germany132 participantsStarted 2024-11-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years of age
✓. Clinical signs consistent with acute ischemic stroke
✓. Subject is able to be treated within 24 hours of stroke symptom onset.
✓. Pre-stroke modified Rankin Score of 0 or 1
✓. NIHSS \> 6 at the time of screening
✓. If intravenous thrombolysis (IVT) is indicated, initiation of IVT should be administered as soon as possible and no later than 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IVT dose for the estimated weight.
✓. Intracranial occlusion defined as Modified Thrombolysis in Cerebral Infarction (mTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
Exclusion criteria
✕. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
What they're measuring
1
Number of Participants With Successful Reperfusion (mTICI 2b-3) Within Three Passes Without Rescue Therapy
Timeframe: intra-procedural
2
Number of Participants With Symptomatic Intracranial Hemorrhage Within 24 (18-36) Hours Post-Procedure
✕. Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
✕. Known serious sensitivity to radiographic contrast agents
✕. Known sensitivity to nickel, titanium metals, or their alloys
✕. Subjects already enrolled in other investigational studies that would interfere with study endpoints
✕. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
✕. Life expectancy of less than 90 days
✕. Clinical presentation suggests a subarachnoid hemorrhage, even if the initial CT or MRI scan is normal.