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:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT03199404
Eligibility Criteria:
Inclusion Criteria:
* Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA)
* Subjects in which the TRAP technique is used for at least the first two thrombectomy passes per occluded vessel
* Subjects that range in age from 18-85
* Subjects with a prestroke modified Rankin scale of 0-1 and presenting with an NIHSS of 8-30
* Subjects that the operator feels may be treated with endovascular therapy
* Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better
* Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration)
* Subjects who have consented in accordance with local Institutional Review Board requirements
Exclusion Criteria:
* Absence of large vessel occlusion on neuroimaging
* Evidence of tandem occlusion on neuroimaging
* Platelet count \< 100 x 10³ cells/mm³ or known platelet dysfunction
* Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging)
* Previously documented contrast allergy that is not amenable to medical treatment
* Women who are pregnant or breastfeeding at time of intervention
* Evidence of brain hemorrhage on CT and/or MRI at presenting hospital
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03199404
Study Brief:
Protocol Section:
NCT03199404