Acute Ischemic Stroke From Large Vessel Occlusion
Conditions
Keywords
flow arrest, flow restriction, funnel, guide catheter, mechanical thrombectomy
Brief summary
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.
Detailed description
Similar to other ancillary devices used in MT, the ANA device is designed to facilitate the delivery of stent retrievers and other catheters during these procedures. Its design aims to enhance procedural success and the efficiency of stent retriever-based MT by enabling flow arrest during clot retrieval. This approach has been shown to improve rates of revascularization and favorable clinical outcomes at three months. The use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction and could achieve acute reperfusion outcomes comparable to commonly used strategies that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a SR. A dual-arm, prospective, randomized study will be conducted to demonstrate the safety and effectiveness of ANA compared to a conventional approach using cleared stent retrievers for MT. The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers: Solitaire, Trevo, and pRESET. Procedural safety will be assessed by comparing the rate of procedure-related sICH within 24 hours of the intervention between study arms.
Interventions
DEVICEANA Funnel Catheter
Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
DEVICEControl
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.
Sponsors
Anaconda Biomed S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Subjects meeting all inclusion criteria will be considered for enrollment in the study. 1. Age 22 to 85 years. 2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative). 3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia. 4. Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points. 5. Pre-ictal mRS score of 0,1 or 2. 6. Treatable within 16 hours of symptom onset, defined as point in time when the subject was last observed to be asymptomatic; treatment start is defined by arterial puncture time. 7. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 8. Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1 segment or, dominant or proximal M2 segment, indicated for mechanical thrombectomy, confirmed with conventional angiography or CTA/MRA. 9. Imaging criteria: * Perfusion weighted criterion: volume of diffusion restriction visually assessed ≤ 50 mL on CTP/MRP, or * CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT/DWI-MRI. (Inclusion of subjects with ASPECTS 5 is permitted at centers performing scoring on MRI) 10. The subject is indicated for a neurovascular thrombectomy procedure with an approved stent retriever per its Instructions for Use. Key
Exclusion criteria
Subjects who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with near-complete reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel. | intra-operative | Reperfusion (eTICI 2c-3) to be assessed by an independent Core Lab. |
| Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure. | Within 24 hours of the procedure | Extent of hemorrhage to be assessed by an independent Core Lab, symptoms to be assessed by the Data Monitoring Committee (DMC). |
Countries
France, Hungary, Spain, Turkey (Türkiye), United States
Contacts
Primary ContactHendrik Lambert
Backup ContactTina Cordaro
Outcome results
None listed