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EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries — ORION  

Iliac Artery Stenosis Clinical Trial

Official title:
A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

Clinical Trial Summary

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Clinical Trial Description

ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00896337
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase Phase 3
Start date May 2009
Completion date December 2013
View Details
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