About this trial
Post-Market Registry
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device* during treatment for acute ischemic stroke.
Participant is 18 years of age or older.
Disqualifiers
Participant who may be unable to complete follow-up within the registry.
Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
Participant is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results based on Principal Investigator's discretion.
Trial population
Patients requiring treatment with Medtronic Neurovascular commercially available devices used during the treatment of acute ischemic stroke (AIS)
Trial design
Cohort
Prospective
Treatments tested in this trial
Mechanical Thrombectomy
DeviceIndex stroke procedure and follow-up visits up to 90 days post index procedure
Treatment groups
Trial outcomes
Primary outcomes
Evaluate device safety
Incidence of Safety Events of Interest through 90-day follow-up
Evaluate device performance
Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.
Evaluate device effectiveness
Functional independence as measured by modified Rankin Scale (mRS) score ≤ 2 at 90-day follow up (mRS scores range from 0 \[no symptoms\] to 6 \[death\]).
Sponsors and contacts
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