NCT00235170

The Arterial Revascularization Therapies Study Part II.

ARTS II: Arterial Revascularization Therapies Study Part II of the Sirolimus-Eluting Bx VELOCITY™ Balloon Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to compare the effectiveness of coronary stent implantation using the sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) free survival at 1 year.

Detailed description

ARTS II is a multicenter, European, open-label, non-randomized, stratified trial in about 45-50 centers which will include six hundred eligible patients with multivessel disease who should be equally treatable by surgery or stenting. In all patients the sirolimus-eluting Bx VELOCITY™ balloon expandable stent of Cordis will be used for treatment.The results of ARTS II will be compared with the by-pass arm of ARTS I as the historical control. It is hypothesized that a similar or higher number of lesions will be treated by stenting. We assume that the use of this eluting stent will not only reduce the rate of MACCE at 30 days, but that it will considerably reduce the need for re-intervention, which was historically 21.0% in ARTS I.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent	Cypher Sirolimus-eluting Coronary stent

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-12-01
• Completion: 2009-04-01
• First posted: 2005-10-10
• Last updated: 2009-05-05

Locations

1 site across 1 country: Netherlands