NCT00217269

The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,548 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.

Detailed description

The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coronary Artery Stenting	Endeavor Drug eluting stent
DEVICE	Coronary Artery Stenting	Taxus Drug Eluting Stent

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-03-01
• Completion: 2011-07-01
• First posted: 2005-09-22
• Last updated: 2012-04-20

Locations

1 site across 1 country: United States