NCT01958294

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Silk Road Medical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Carotid Stenosis
• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	MICHI Neuroprotection System

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2013-10-09
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

1 site across 1 country: United Kingdom