An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)

PHASE3TerminatedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

October 31, 2012

Conditions
Atherosclerotic Coronary Artery Disease
Interventions
DEVICE

NEVO™ Sirolimus-eluting Coronary Stent System

"Design Original Protocol~Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting."

DEVICE

XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)

Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.

Trial Locations (3)

Unknown

Erasmus MC - Thoraxcenter, Rotterdam

Hospital Universitari Clinic de Barcelona, Barcelona

Inselspital, Bern

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cordis Corporation

INDUSTRY