Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01958294
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2013-10-04
Brief Title:
The MICHI NEUROPROTECTION SYSTEM Evaluation of Performance in Carotid Artery Stent Procedures The LOTUS Study
Sponsor:
Silk Road Medical
Organization:
Silk Road Medical
Study Overview
Official Title:
The MICHI NEUROPROTECTION SYSTEM Evaluation of Performance in Carotid Artery Stent Procedures The LOTUS Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTUS
Brief Summary:
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System MICHI NPS or MICHI Neuroprotection System with filter MICHI NPSf 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
Detailed Description:
Cerebral embolization during carotid artery stenting CAS can often precipitate severe adverse neurological effects Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy CEA Many currently available embolic protection devices however have limited efficacy in capturing microembolic debris liberated during stenting pre-dilatation and post-dilatation Furthermore distal protection systems are limited by the need to cross the lesion prior to deployment Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed
Cerebral protection with carotid flow reversal is a method that was developed by Parodi et al 2005 as an alternative to the use of distal protection devices While novel in its approach this method too has its limitations Criado et al 2004 developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis that can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy
Cerebral protection with carotid flow reversal is a method that was developed by Parodi et al 2005 as an alternative to the use of distal protection devices While novel in its approach this method too has its limitations Criado et al 2004 developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis that can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None