NCT00715884

Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (ELITE).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

Detailed description

A prospective, single-blind, randomized, multicenter, two arm study. The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.

Conditions

• Coronary Artery Disease
• Coronary Atherosclerosis

Interventions

Type	Name	Description
DEVICE	CYPHER® ELITE™ Sirolimus-Eluting Stent System	Drug eluting stent
DEVICE	CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System	Drug eluting stent

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-03-01
• Completion: 2014-09-01
• First posted: 2008-07-15
• Last updated: 2014-01-20
• Results posted: 2011-05-06

Locations

1 site across 1 country: United States