NCT00217256

The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial

A Randomized Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter.

Detailed description

The ENDEAVOR III Trial is a prospective, multi-center, single-blind, randomized trial that enrolled 436 patients at 29 sites in the US. The purpose of this trial is to demonstrate the equivalency of in-segment late lumen loss at 8 months between the Endeavor stent and the Cypher stent for the treatment of single de novo lesions in native coronary arteries 2.5-3.5 mm in diameter. Patients were randomized to receive the Endeavor stent or the Cypher Sirolimus-Eluting Coronary Stent System. Enrollment was completed in September 2004.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Stenting	Endeavor Drug Eluting Stent
DEVICE	Percutaneous Coronary Stenting	Cypher Drug Eluting Stent

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-05-01
• Completion: 2010-12-01
• First posted: 2005-09-22
• Last updated: 2011-06-27