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Proximal Protection With The Mo.Ma Device During Carotid Stenting

NCT00744523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2016-02-26

Study results available
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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

Conditions

  • Carotid Artery Disease

Interventions

DEVICE

Mo.Ma cerebral protection device

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.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Gary Ansel, MD · Midwest Cardiology Research Foundation

  • L. Nelson Hopkins, MD · University at Buffalo Neurosurgery

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744523 on ClinicalTrials.gov