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Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis

Carotid Artery Stenosis Clinical Trial

Official title:
Pivotal Study of the MicroVention, Inc. Carotid Artery Stent System Used in Conjunction With the Nanoparasol® Embolic Protection System for the Treatment of Carotid Artery Stenosis in Patients at Elevated Risk for Adverse Events From Carotid Endarterectomy.(CONFIDENCE Trial)

Clinical Trial Summary

A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of MicroVention, Inc. Roadsaver™ Carotid Stent System used in conjunction with the Nanoparasol® embolic protection system for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy.

Clinical Trial Description

Up to 295 patients will be enrolled for this study. All potential patients being considered for the study should have been diagnosed with significant carotid artery stenosis and be considered a high perioperative risk for carotid endarterectomy. Patients will be evaluated through screening, pre-procedure, index procedure, post-procedure. Follow-up visits will be completed at 30 days, 6 months, and 12, 24, and 36 months post-procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02657707
Study type Interventional
Source Microvention-Terumo, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date April 21, 2016
Completion date May 2024
View Details
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