The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study) (LOTUS)
|ClinicalTrials.gov Identifier: NCT01958294|
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis Carotid Artery Disease||Device: MICHI Neuroprotection System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
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
- Composite of any stroke, myocardial infarction and death [ Time Frame: 30-days post-procedurally ]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) ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958294
|Newcastle upon Tyne Hospitals NHS Foundation Trust|
|Newcastle upon Tyne, England, United Kingdom, NE7 7DN|
|Principal Investigator:||Sumaira Macdonald, FRCP FRCR PhD EBIR||Newcastle upon Tyne Hospitals NHS Foundation Trust|