Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent

NACompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

August 31, 2011

Study Completion Date

April 30, 2016

Conditions
Coronary Artery Disease
Interventions
DEVICE

PROMUS(TM) Element (TM) Stent System

The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.

DEVICE

Evolution Stent System

The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).

Trial Locations (29)

1640

Middlemore Hospital, Otahuhu

2020

Academisch Ziekenhuis Middelheim, Antwerp

2100

Rigshospitalet Thoraxkirurgisk Klinik RT, Copenhagen

3000

UZ Gasthuisberg, Leuven

3600

Ziekenhuis Oost Limburg, Genk

4000

Centre Hospitalier Universitaire Sart Tilman Liège, Liège

6160

Fremantle Hospital, Fremantle

8200

Skejby Sygehus, Aarhus

9016

Dunedin Hospital, Dunedin

28040

Hospital Clinico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

31059

Hôpital Rangueil, Toulouse

31087

Clinique Pasteur, Toulouse

75014

Hôpital Cochin, Paris

79182

Falu lasarett, Falun

83190

Polyclinique Les Fleurs, Ollioules

QLD 4032

The Prince Charles Hospital, Chermside

VIC 3168

Monash Medical Centre, Clayton

VIC 3065

St. Vincent's Hospital (Melbourne), Fitzroy

0622

North Shore Hospital, Takapuna

85-094

Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy, Bydgoszcz

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

756 52

Uppsala Akademiska Hospital, Uppsala

BT 12 6BA

Royal Victoria Hospital, Belfast

CB3 8RE

Papworth Hospital, Cambridge

G81 4HX

Golden Jubilee National Hospital, Clydebank

L14 3PE

Liverpool Heart and Chest Hospital, Liverpool

0X3 9DU

John Radcliffe Hospital, Oxford

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY