Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.

Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System

MICHI Neuroprotection System

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Average Height

Average Weight

Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.

Composite of Any Stroke, Myocardial Infarction and Death

Acute device success - Defined as MICHI™ NPS was delivered (vascular access achieved), reverse flow was attempted and established and the device retrieved / removed from vasculature.

Acute Device Success

Procedure Success - Procedural success is the ability to deliver therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and the ability to provide embolic protection throughout the procedure with the freedom of device related Major Adverse Events at 30 days.

Procedural Success

Subjects enrolled into this study will be male or female subjects who are candidates for carotid angioplasty and stenting, who, after meeting all of the eligibility criteria, undergo transcervical Carotid Artery Stenting with carotid flow reversal using the MICHI Neuroprotection System.
MICHI Neuroprotection System The MICHI Neuroprotection System (MICHI NPS) is a flow reversal circuit consisting of two proprietary sheaths connected by standard surgical tubing. The sheaths each have a standard hemostasis valve and sidearm. An in-line flow regulator allows the clinician to modify the flow through the circuit (either high flow or low flow) in addition to permitting temporary cessation of flow.
The system permits transcervical access to the carotid lesion, and the flow reversal through the circuit re-directs emboli that are liberated during carotid angioplasty and stent delivery.

lotus tetragonolobus/infarction

The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)

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