CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 262 enrolled
Drug / intervention
Mo.Ma cerebral protection devicedevice
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.

Search/NCT00744523
NCT00744523N/ACompleted
CompareCT.gov

ARMOUR: Proximal Protection With The Mo.Ma Device During Carotid Stenting

Medtronic Endovascular·interventional·Posted Sep 1, 2008·Updated Feb 26, 2016

In Brief

A clinical study evaluating Mo.Ma cerebral protection device for Carotid Artery Disease. Completed, enrolled 262 participants across 2 sites.

Detailed Summary

The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery stenting

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2008
Enrollment StartSep 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.8 years ago

Interventions

Mo.Ma cerebral protection devicedevice

Proximal embolic protection based on the principle endovascular clamping consisting of a catheter with two compliant balloons. Mo.Ma is designed to achieve cerebral protection by proximal blood flow blockage at the carotid bifurcation: antegrade and retrograde flow blockage are achieved by proximal balloon occlusion of the CCA and distal balloon occlusion of the ECA. Cerebral protection is established prior to the initial wire passage through the stenosis and maintained during the entire procedure. Mo.Ma provides withdrawal of embolic particles by allowing manual syringe aspiration of any micro-emboli at the end of the procedure before restoring blood flow through the stented vessel.