Post-Market Registry
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation of safety and effectiveness of Medtronic Neurovascular commercially available products used in the treatment of acute ischemic stroke.
Study Type
OBSERVATIONAL
Enrollment
1,500
Index stroke procedure and follow-up visits up to 90 days post index procedure
McLaren Flint Hospital
Flint, Michigan, United States
RECRUITINGBuffalo General Medical Center
Buffalo, New York, United States
RECRUITINGUniversity of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGEvaluate device safety
Incidence of Safety Events of Interest through 90-day follow-up
Time frame: From Day 0 to 90 days post-procedure
Evaluate device performance
Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.
Time frame: Day 0 - end of index stroke 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 \[death\]).
Time frame: From Day 0 to 90 days post-procedure
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