I63
Conditions
Interventions
Group 1: Intervention group
Intervention: Eligible subjects will be treated with the Ceretrieve device per its instruction-for-use.
For the thrombectomy procedure, the access site will be achieved thr
Sponsors
Ceretrieve Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years of age 2. Clinical signs consistent with acute ischemic stroke 3. Subject is able to be treated within 24 hours of stroke symptom onset. 4. Pre-stroke modified Rankin Score of 0 or 1 5. NIHSS > 6 at the time of screening 6. 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. 7. 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: 1. Intracranial internal carotid artery 2. M1 and/or M2 segment of the MCA 3. Vertebral artery 4. Basilar artery Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch. 8. A valid completed informed consent in accordance with the local ethics committee regulations.
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant or lactating or has a positive pregnancy test at time of admission. 2. Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke 3. Known serious sensitivity to radiographic contrast agents 4. Known sensitivity to nickel, titanium metals, or their alloys 5. Subjects already enrolled in other investigational studies that would interfere with study endpoints 6. 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.) 7. Life expectancy of less than 90 days 8. Clinical presentation suggests a subarachnoid hemorrhage, even if the initial CT or MRI scan is normal. 9. Suspicion of aortic dissection 10. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments. 11. Known to currently use or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day). 12. Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device 13. Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure 14. Angiographic evidence of carotid dissection 15. Imaging exclusion criteria: • CT or MRI evidence of hemorrhage on presentation • CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma) • CT or MRI evidence of cerebral vasculitis • CT or MRI-DWI showing ASPECTS 0-5 (or pc-ASPECTS 0-6 in the posterior circulation). Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 70cc. • CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent • Any imaging evidence that suggests, in the opinion of the investigator, that the subject is not appropriate for mechanical thrombectomy intervention while utilizing an aspiration approach (e.g. inability to navigate to the target lesion, moderate/large infarct with poor collateral circulation, etc.). 16. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety & efficacy of the Ceretrieve device within 24 hours post procedure. Perfomance 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 sICH* rates within 24 (18-36) hours of the study procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the safety of the Ceretrieve device within 90 days (±14-days) post procedure. Rates of modified First-Pass Effect (mFPE) defined as mTICI 2b-3 with first-line Ceretrieve aspiration. • Rates of First-Pass Effect (FPE) defined as mTICI 2c-3 with first-line Ceretrieve aspiration. • mRS scores at 90 days follow-up including the rates of functional independence (mRS 0-2) • Rates of mTICI 2c-3 within the first 3 passes of Ceretrieve aspiration. • Time from groin puncture to complete recanalization (TICI = 2b) in patients after first-line aspiration treatment as seen on final angiography. • mRS at discharge • NIHSS score at 24 hours and 3-5 days or discharge (whatever comes first), and 90 days, total and subscale scores • Rates of final recanalization (TICI = 2b and = 2c) after thrombectomy using an additional device as seen on final angiography. • Hospital length of stay Safety Endpoints: • All-cause mortality at 90±14 days • Intracranial hemorrhage within 24h (18h-36h) of procedure according to the Heidelberg Bleeding Classification • Embolization to previously uninvolved vascular territories. • Device or procedure related AEs at 90 days follow up. | — |
Countries
Germany, Israel, Turkey
Contacts
Public ContactMarkus Alfred Möhlenbruch
Universitätsklinikum Heidelberg
Outcome results
None listed