The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be followed immediately post-op and at 30 days.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)|
- Composite of any stroke, myocardial infarction and death [ Time Frame: 30-days post-procedurally ] [ Designated as safety issue: Yes ]Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.
- Acute Device Success [ Time Frame: Intra procedural (1 day) ] [ Designated as safety issue: No ]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.
- Procedural Success [ Time Frame: Through 30-day Follow-up period ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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.
Device: MICHI Neuroprotection System
|Contact: Sumaira Macdonald, FRCP FRCR PhD EBIR||0191 email@example.com|
|Newcastle upon Tyne Hospitals NHS Foundation Trust||Recruiting|
|Newcastle upon Tyne, England, United Kingdom, NE7 7DN|
|Contact: Sumaira Macdonald firstname.lastname@example.org|
|Principal Investigator: Sumaira Macdonald, FRCP FRCR PhD EBIR|
|Sub-Investigator: Mike Wyatt, MB BS, MSc, FRCS|
|Sub-Investigator: Mike Clarke, MB Ch.B, FRCS|
|Sub-Investigator: David Lambert, BA MS BS FRCS|
|Sub-Investigator: Tim Lees, MB CH.B FRCS|
|Sub-Investigator: Lucy Wales, MB Ch.B FRCS PH.D|
|Sub-Investigator: Gerard Stansby, BA, M.B.B. Chir, MA, FRCS|
|Sub-Investigator: Ralph Jackson, MB BS, MRCP, FRCR|
|Sub-Investigator: Rob Williams, MRCS, FRCR|
|Principal Investigator:||Sumaira Macdonald, FRCP FRCR PhD EBIR||Newcastle upon Tyne Hospitals NHS Foundation Trust|