NCT00130546

Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE-RACE Study)

A Prospective, Randomized Intra-Individual Study With the Sirolimus Coated Cypher Select(TM) and the Paclitaxel(TM) Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).

Detailed description

This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers). A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to \< 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel-eluting TAXUS(TM)	TAXUS(TM) Paclitaxel-eluting stent
DEVICE	Sirolimus eluting Cypher Select(TM)	Sirolimus eluting Cypher Select(TM) stent

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-08-15
• Last updated: 2009-05-15

Locations

1 site across 1 country: Germany