Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents

PHASE4CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

May 31, 2011

Study Completion Date

June 30, 2012

Conditions
StentsNeointimal Proliferation
Interventions
DEVICE

Percutaneous coronary intervention with stent implantation

"Percutaneous coronary intervention with implantation of either:~\- a XIENCE® V everolimus eluting coronary stent in one of the following sizes: 3.0 x 18 mm, 3.0 x 28 mm, 2.5 x 18 mm, 2.5 x 28 mm (DES group),~or:~\- a Coroflex Blue® coronary stent postdilated with a Sequent Please® paclitaxel-eluting balloon in one of the following size combinations (stent / balloon): 3.0 x 16 mm / 3.0 x 20 mm, 3.0 x 25 mm / 3.0 x 30 mm, 2.5 x 16 mm / 2.5 x 20 mm, 2.5 x 25 mm / 2.5 x 30 mm (BMS/DEB group)"

Trial Locations (1)

07740

University Hospital of Jena, 1st Medical Department, Division of Cardiology, Jena

All Listed Sponsors
collaborator

B. Braun Melsungen AG

INDUSTRY

collaborator

Abbott Medical Devices

INDUSTRY

collaborator

Boston Scientific Corporation

INDUSTRY

lead

University of Jena

OTHER