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Tests treatment safety and results for Acute Ischemic Stroke
Official title Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
ClinicalTrials.gov ID: NCT06733246
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- 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
- people 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...
See the full eligibility 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...
- 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\...
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- 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
- people 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...
- Life expectancy of less than 90 days
- Clinical presentation suggests a subarachnoid hemorrhage, even if the initial CT or MRI scan is normal.
- Suspicion of aortic dissection
- 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.
- Known to currently use or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- 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
- Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
- Angiographic evidence of carotid dissection
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.