Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.

NACompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

July 31, 2016

Conditions
Coronary Artery DiseaseCoronary Restenosis
Interventions
DEVICE

Percutaneous coronary intervention

Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.

DEVICE

Percutaneous coronary intervention

Up to 70 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Orsiro drug eluting stent.

Trial Locations (14)

10117

Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin, Berlin

12203

Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin, Berlin

22527

Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg

23795

Heart Center Segeberger Kliniken, Bad Segeberg

32429

Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden, Minden

45138

Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Essen

48149

Universitätsklinikum Münster, Klinik für Kardiologie, Münster

78050

Innere Medizin III Kardiologie, Kliniken Villingen, Villingen-Schwenningen

79189

Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen

80804

Klinikum Schwabing, Munich

81337

LMU - Klinikum der Universität München, Munich

81925

Klinikum Bogenhausen, Munich

96450

Kardiologie - Angiologie - Pneumologie, Klinikum Coburg, Coburg

LV-1002

Cardiology, Pauls Stradins Clinical University Hospital, Riga

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik AG

INDUSTRY

NCT01651390 - Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis. | Biotech Hunter | Biotech Hunter