Acute Ischemic Stroke, Large Vessel Occlusion
Conditions
Keywords
Acute Ischemic Stroke (AIS), mechanical thrombectomy, stent retriever
Brief summary
The goal of this study is to evaluate the safety and performance of the CONDA stent retriever in patients with acute ischemic stroke due to large vessel occlusion, treated within 24 hours of symptom onset. The main objectives are: * To determine the rate of device success, defined as the ability of the CONDA retriever to reach the blocked vessel, be deployed and retrieved successfully, and facilitate reperfusion. * To evaluate safety, measured as the rate of symptomatic intracranial hemorrhage within 24 hours of the procedure. The use of CONDA in this study follows the same approach as other CE-marked stent retrievers. Supportive devices (such as long sheaths, guide catheters, balloon catheters, distal access catheters, the ANA funnel catheter, microcatheters, and microwires) may be used according to investigator preference and local practice, in line with their labeling and instructions for use. Participants will: * Be evaluated using standard clinical and imaging assessments to confirm eligibility. * Undergo mechanical thrombectomy with the CONDA device, with or without supportive devices as selected by the treating physician. * Have standard follow-up evaluations to assess treatment safety and effectiveness.
Detailed description
ARTEMIS is a pilot prospective, multi-center, single-arm, open-label, interventional study. Standard of care clinical and imaging stroke assessments will determine subject eligibility. The objective of this study is to assess the performance, safety and preliminary efficacy of mechanical thrombectomy (MT) using the CONDA device in its intended use as a stent retriever to enable the entrapment and removal of clotted blood in the neurovasculature in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset. The ARTEMIS study is designed to demonstrate that the use of CONDA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedures.
Interventions
DEVICEMechanical Thrombectomy using the CONDA Stent Retriever
Intravenous sedation, local or general anesthesia, and anticoagulation management will be administered following the institution's standard of care to ensure subject safety and comfort. These procedures should be applied to the target population at the discretion of the investigator and in accordance with clinical guidelines. The use of CONDA is no different than that established for other CE marked stent retrievers. The use of supportive devices including, long sheaths, guide catheters with our without balloons, distal access catheters, ANA funnel catheter, microcatheters and microwires, along with the CONDA device, will be guided by operator preference and/or center established practices. Operators are required to use these devices according to their labeling and instructions for use.
Sponsors
Anaconda Biomed S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Independent imaging core will evaluate reperfusion outcomes
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 85 years. 2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative). 3. 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 24 hours of stroke symptom onset. 7. If indicated, thrombolytic therapy shall be initiated following recommendations established by the AHA/ASA and/or ESO Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 8. Extended Thrombolysis in Cerebral Infarction (eTICI) Score 0 - 1, confirmed by angiography or CTA/MRA of the: 1. Intracranial internal carotid artery (ICA) 2. Middle cerebral artery - M1 segment 3. Middle cerebral artery - M2 proximal or dominant segments 9. Imaging criteria: * Alberta Stroke Program Early CT Score (ASPECTS) 6 to 10 on baseline CT or DWI-MRI. * If automated assessment, core volume of ≤50 cc on CTP/ DWI-MRI.
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device success | Day 0 Index Procedure | The rate of device success is defined as the ability of the CONDA retriever to reach the target occluded vessel, be deployed and retrieved successfully, while facilitating reperfusion. Success will be determined if both of the following criteria are met: a) Device Performance, b) Clinical Performance |
| Incidence of symptomatic intracranial hemorrhage | 24 hours (-8/+12) of the index procedure | (sICH) defined per SITS-MOST criteria, attributable to the device or procedure, occurring within 24 hours (-8/+12) of the index procedure and assessed by the Imaging Core Lab and Data Monitoring Committee (DMC). |
Countries
Hungary, Spain
Contacts
Primary ContactHendrik Lambert, PhD
Backup ContactTina Cordaro, MPA, RN, BSN
Outcome results
None listed