NCT00165035

Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,701 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.

Detailed description

Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	CoStar Paclitaxel Drug Eluting Coronary Stent System	Drug eluting stent
DEVICE	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent	Drug eluting stent

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-01-01
• Completion: 2011-07-01
• First posted: 2005-09-14
• Last updated: 2011-08-04

Locations

2 sites across 1 country: United States