NCT00234455

A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.

An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.

Detailed description

This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug eluting-stent	PCI
DEVICE	drug-eluting stent	PCI

Timeline

• Start date: 2001-06-01
• Primary completion: 2002-10-01
• Completion: 2007-04-01
• First posted: 2005-10-07
• Last updated: 2008-04-30

Locations

1 site across 1 country: Italy