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Proximal Protection With The MO.MA Device During Carotid Stenting

2014-08-27 03:28:00 | BioPortfolio

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

Description

Test Device:

Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device (Mo.Ma). Single size catheter device with a 9F introducer sheath compatible shaft (outer diameter) and a 6F 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.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Carotid Artery Disease

Intervention

Carotid Artery Stenting with cerebral protection with the MO.MA device

Location

University at Buffalo Neurosurgery
Buffalo
New York
United States
14209

Status

Completed

Source

Invatec S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:00-0400

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Medical and Biotech [MESH] Definitions

Artery formed by the bifurcation of the internal carotid artery (CAROTID ARTERY, INTERNAL). Branches of the anterior cerebral artery supply the CAUDATE NUCLEUS; INTERNAL CAPSULE; PUTAMEN; SEPTAL NUCLEI; GYRUS CINGULI; and surfaces of the FRONTAL LOBE and PARIETAL LOBE.

A polygonal anastomosis at the base of the brain formed by the internal carotid (CAROTID ARTERY, INTERNAL), proximal parts of the anterior, middle, and posterior cerebral arteries (ANTERIOR CEREBRAL ARTERY; MIDDLE CEREBRAL ARTERY; POSTERIOR CEREBRAL ARTERY), the anterior communicating artery and the posterior communicating arteries.

Damages to the CAROTID ARTERIES caused either by blunt force or penetrating trauma, such as CRANIOCEREBRAL TRAUMA; THORACIC INJURIES; and NECK INJURIES. Damaged carotid arteries can lead to CAROTID ARTERY THROMBOSIS; CAROTID-CAVERNOUS SINUS FISTULA; pseudoaneurysm formation; and INTERNAL CAROTID ARTERY DISSECTION. (From Am J Forensic Med Pathol 1997, 18:251; J Trauma 1994, 37:473)

Blood clot formation in any part of the CAROTID ARTERIES. This may produce CAROTID STENOSIS or occlusion of the vessel, leading to TRANSIENT ISCHEMIC ATTACK; CEREBRAL INFARCTION; or AMAUROSIS FUGAX.

Pathological conditions involving the CAROTID ARTERIES, including the common, internal, and external carotid arteries. ATHEROSCLEROSIS and TRAUMA are relatively frequent causes of carotid artery pathology.

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