Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT05632458
Eligibility Criteria:
Inclusion criteria:
Clinic
Age ≥18 and ≤85 years. Informed consent obtained from the patient or an acceptable surrogate for the patient (ie, next of kin or legal representative).
A new disabling focal neurological deficit compatible with acute cerebral ischemia.
Baseline NIHSS obtained before the procedure, ≥ 6 points. Preictal mRS score of 0 or 2. Treatable as soon as possible and at least within 24 hours of symptom onset, defined as the time the patient was last seen well (at baseline).
Patients for whom IV t-PA is indicated and who are available for treatment are treated with IV t-PA. For those patients for whom IV t-PA is indicated and available for treatment, IV t-PA should be administered as recommended in the AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke ( AIS).
Neuroimaging
Occlusion (flow TICI 0 or TICI 1), of the terminal internal carotid artery, segments or distal M1 of the basilar or middle cerebral artery, suitable for mechanical embolectomy, confirmed by conventional angiography.
The patient is indicated for neurothrombectomy treatment by the Interventionist.
Participating NRIs will have to complete a teaching module on the DS-EVT
Exclusion criteria:
Clinic
Functional disability prior to stroke on the modified Rankin scale (mRS \>2). Initial treatment with a different thrombectomy device. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
Known bleeding diathesis, coagulation factor deficiency, or known oral anticoagulant therapy with INR \> 3.0.
Baseline platelet count \< 50,000. Serious, advanced or terminal illness with an expected life expectancy of less than six months.
Subjects with identifiable intracranial tumors. Brain vasculitis. Evidence of active systemic infection. Known current use of cocaine at the time of treatment. Woman of childbearing age who is known to be pregnant, and/or breastfeeding, or who has a positive pregnancy test at the time of admission.
Patient participating in a study involving an investigational drug or device that may affect this study.
Patients who are unlikely to be available for a 90-day follow-up (eg, homeless, visitor from abroad).
Neurological imaging
Hypodensity on CT or diffusion-restricted resulting in an ASPECTS score of \< 6 on CT or \< 5 on DMR (diffusion-weighted MRI).
Evidence of hemorrhage on CT or MRI (the presence of microbleeds is allowed). Angiographic evidence of carotid artery dissection, high-grade stenosis impeding access to the clot, or vasculitis.
Significant mass effect with midline shift. Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
Patients with occlusions in multiple vascular territories (for example, bilateral anterior circulation or anterior/posterior circulation).
Evidence of intracranial tumor (except small meningiomas). Suspected aortic dissection, suspected septic embolus, or suspected bacterial endocarditis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05632458
Study Brief:
Protocol Section:
NCT05632458