None listed
Conditions
Interventions
Medical Device : We aim to investigate the feasibility and safety of two groups, classified based on the vacuum formation devices used during aspiration thrombectomy: one group utilizing the Synergy a
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, and under 80 years of age. 2. New focal neurological deficits associated with acute cerebral ischemia. Focal neurological deficits include a decrease in the level of consciousness, gaze palsy, visual field loss, unilateral facial paralysis, weakness in the upper or lower extremities, sensory loss, ataxia, aphasia, dysarthria, neglect, and inattention. 3. In cases where patients presenting symptoms as described in item 2 have been examined by the hospital's neurologists, and where the decision to perform an endovascular thrombectomy has been made following discussion with radiologists.
Exclusion criteria
Exclusion criteria: Clinical Criteria 1. Deficiency of blood coagulation factors, known hemorrhagic diathesis or tendency, and receiving anticoagulation therapy with an INR of 3.0 or greater. 2. Platelet count less than 50,000/µL in baseline blood tests. 3. History or blood lab findings of renal dysfunction (GFR < 30 mL/min). 4. Evidence of active systemic infection such as infective endocarditis. 5. Cases where femoral artery puncture is not possible. 6. A severe allergy to iodinated contrast medium or the presence of contraindications to its use. 7. Pregnant women or women with a possibility of pregnancy based on their medical history. 8. Cases where the benefits anticipated from the procedure are expected to be limited for other reasons. Radiological Criteria 1. Diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage on baseline imaging studies. 2. Cases where any hemorrhage cannot be ruled out on baseline imaging studies. 3. Angiographic evidence of dissection in the aorta, common carotid artery, internal carotid artery, etc. 4. Known or suspected underlying intracranial atherosclerotic lesion that appears related to the target occlusion. 5. Tandem occlusion. 6. Cases where unstable guide support is strongly anticipated due to excessive vascular tortuosity. 7. Evidence of an intracranial tumor. 8. Suspected midline shift. 9. Cases where the operator deems aspiration thrombectomy inappropriate considering baseline imaging findings such as tortuosity. 10. Cases where the operator deems that the procedure risk is increased due to other radiological findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured negative pressure.;Modified TICI 2b-3 achieved during the initial three attempts of aspiration thrombectomy.;Device-related serious adverse events.;Symptomatic intracranial hemorrhage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total procedure time.;First pass effect.;Final modified TICI 2b-3.;Procedure-related serious adverse events.;Device preparation time.;The amount of blood loss.;Survey (procedural convenience, procedural satisfaction, device preparatio convenience etc.). | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-Tae Yoon
Asan Medical Center
Outcome results
None listed