At a glance
ClinicalIndex Comparison RecordN/ACompleted· 12 enrolled
Drug / intervention
MICHI Neuroprotection Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
In Brief
A clinical study evaluating MICHI Neuroprotection System for Carotid Stenosis and Carotid Artery Disease. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Stenosis, Carotid Artery Disease
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedOct 2013
Primary CompletionJul 2014
Study CompletionAug 2014
TodayJul 2026
First PostedOct 9, 2013
Enrollment StartAug 1, 2011
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.7 years ago
Interventions
MICHI Neuroprotection Systemdevice