NCT00744523

Proximal Protection With The Mo.Ma Device During Carotid Stenting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Test Device: Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device. Single size catheter device with a 9 French introducer sheath compatible shaft (outer diameter) and a 6 French compatible working channel (inner diameter), integrating two compliant balloons intended to achieve endovascular clamping of external carotid arteries (ECA) 3-6 mm in diameter and common carotid arteries (CCA) 5-13 mm in diameter. Primary Objective: Evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the treatment of internal carotid artery (ICA) stenoses, which may or may not involve the bifurcation of the CCA, in subjects considered to be at high surgical risk for complications during carotid endarterectomy (CEA). Primary Endpoint: Major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-09-01
• Last updated: 2016-02-26
• Results posted: 2010-05-05

Locations

2 sites across 1 country: United States