Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study — ASTI  

Stroke Clinical Trial

Official title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

Status Completed

Clinical Trial Summary

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

Clinical Trial Description

According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Stenosis
• Stroke

• NCT number: NCT01133327
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Completion date: June 2012