Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235170
Status:
COMPLETED
Last Update Posted:
2009-05-05
First Post:
2005-10-04
Brief Title:
The Arterial Revascularization Therapies Study Part II
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
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
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTS II
Brief 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 treatmentThe 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 210 in ARTS I
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None