NCT00233805

The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.

A Randomized Study With the Sirolimus Coated Modified BX Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Cordis US Corp. · Industry
• 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 coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.

Detailed description

This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to the bare metal BxTM VELOCITY stent, both mounted on the Raptorâ Rapid Exchange Stent Delivery System. A total of 220 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be randomized to the coated or uncoated BX VELOCITY stent. Therefore, neither the Investigator nor the patient will know which stent will be implanted. Patients will be followed for twelve months post-procedure, with all patients having a repeat angiography at 6 months. An ancillary study with in-stent IVUS measurements at 6 months follow-up will be performed in all patients of 6 pre-selected clinical sites. It is assumed that these sites will enroll more than 90 patients.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus coated Bx Velocity™	drug-eluting stent
DEVICE	Bare metal Bx Velocity™	bare-metal stent

Timeline

• Start date: 2000-08-01
• Completion: 2007-12-01
• First posted: 2005-10-06
• Last updated: 2008-08-06

Locations

1 site across 1 country: France